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Effects of progestin-only long-acting reversible contraception on metabolic markers in obese women

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Effects of progestin-only long-acting reversible contraception on metabolic markers in obese women

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Content i

EFFECTS OF PROGESTIN-ONLY LONG-ACTING REVERSIBLE
CONTRACEPTION ON METABOLIC MARKERS IN OBESE WOMEN

by

Nicole Mosteller Bender

________________________________________________________________

A Thesis Presented to the
FACULTY OF THE USC GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(CLINICAL AND BIOMEDICAL INVESTIGATIONS)

May 2011

Copyright 2011 Nicole Mosteller Bender
ii
TABLE OF CONTENTS

List of Tables iii
Abstract iv
Introduction 1
Objective 4
Methods 5
Results 8
Figure. Enrollment Flow Sheet 8
Discussion 12
References 15

iii
LIST OF TABLES

Table 1. Demographic and baseline characteristics 9

Table 2. Mean values of components of metabolic syndrome
at baseline 10

Table 3. Mean change in components of metabolic syndrome
among ALL women 11

Table 4. Mean change of components of metabolic syndrome
between groups 11

iv

ABSTRACT

Background:
The obesity epidemic among reproductive age women in the United States
necessitates that contraceptives be studied in this population given the need for
effective long-acting contraception that does not increase their already elevated
risk for cardiovascular and metabolic disease. Previous research suggests that
progestin-only contraception may decrease HDL-C cholesterol. While a small
decline in HDL-C may not affect the long-term risks for normal weight women,
this may have a more profound clinical impact in obese women (BMI ≥30 kg/m
2
).
The metabolic effects of the levonorgestrel-releasing intrauterine system (LNG-
IUS) have been studied in normal weight women, but not in obese women.

Objective:
The primary objective of this study is to determine if treatment with the
levonorgestrel-releasing intrauterine system (LNG-IUS) alters metabolic markers
and components of metabolic syndrome in obese women differently than obese
users of non-hormonal contraception (NHC).

v
Methods:
This study is a prospective cohort of reproductive age women with BMI ≥30
kg/m
2
who do not intend to change lifestyle behaviors during the 6 month study
period. Planned enrollment includes 20 subjects; 10 initiating LNG-IUS, and 10
using non-hormonal methods. Components of metabolic syndrome [fasting blood
glucose (FBG), HDL cholesterol (HDL-C) and triglycerides (TG), systolic and
diastolic blood pressure (SBP, DBP), abdominal circumference (AC),] will be
evaluated at baseline, 3 months and 6 months after the initiation of use. At all
time points, subjects will complete a validated questionnaire regarding diet and
exercise habits.

Results:
Twelve subjects have completed both the baseline and Month 3 visit; 6 subjects
using LNG-IUS and 6 subjects using non-hormonal method of contraception
(NHC). Subjects of both groups were similar in mean age, parity, BMI, and
history of gestational diabetes. There were more African-American women that
chose NHC and those that chose NHC were also more likely to have a family
history of diabetes (p=0.01 and p=0.04, respectively). Baseline parameters of
metabolic syndrome did not differ between the two groups with the exception of
systolic blood pressure (119 mm Hg in NHC vs 110 mm Hg in LNG-IUS, p=0.03).
The LNG-IUS group had mean decrease in HDL-C of 8.5 mg/dL and mean
increase in fasting glucose of 10.7 mg/dL at 3 months, while the NHC group had
vi
mean increase in HDL-C of 0.5 mg/dL and meaning increase in fasting glucose
of 1.7 mg/dL. Although these were considered clinically significantly, they were
not statistically significantly different than the non-hormonal group (p=0.06 and
p=0.09, respectively).

Conclusion:
There is a clinically significant decrease in HDL-C and increase in fasting glucose
among obese women using LNG-IUS during the first three months of use. Since
it has been shown that increasing HDL-C levels by as little as 1mg/dL has
significant impact in reducing cardiovascular risk by 2-3%, this decline in HDL-C
levels may be concerning if it persists over the longer follow-up period. This
study found that obese women may have different metabolic responses to
progestin-only contraception than non-obese women.

1
INTRODUCTION

The prevalence of obesity (BMI ≥30kg/ m
2
) has steadily increased throughout the
United States in recent years with the prevalence in California reaching 23.7% in
2008.
1
While obesity has substantial adverse long-term health effects for all
individuals, the immediate importance of obesity for women of reproductive age
is profound. Complications of pregnancy occur more frequently in obese than
normal weight women.
2
Since complications of pregnancy are more common in
the obese population, the need for effective contraception is of extreme
importance. There is also increasing evidence that estrogen containing
contraceptive methods increases the risk for venous thromboembolism in obese
women more than in women without obesity.
3
However, both the World Health
Organization and the Centers for Disease Control in the United States lists
estrogen-containing methods as Class 2 for obese women indicating that the
benefit from these contraceptive methods generally outweigh the risks.
Progestin-only methods, however, are classified as Class 1 (without restrictions)
in obese women over age 18
4,5
and may be preferred for use in obese women.

Obesity also places these women at risk for the development of Type 2 diabetes,
dyslipidemia and hypertension. These diseases are often preceded by the
Metabolic Syndrome. Metabolic Syndrome was first described in 1989 as
“Syndrome X.” Metabolic Syndrome was defined by the Third National
2
Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III) in 2001.
6

By definition an individual must have 3 of the following 5 criteria: (1) abdominal
obesity with a waist circumference of >35 inches or ≥88cm in women, (2) serum
triglycerides ≥150 mg/dL, (3) serum HDL Cholesterol (HDL-C) <50 mg/dL in
women, (4) SBP ≥130 mm Hg and DBP ≥85 mm Hg, and (5) fasting glucose
≥110 mg/dL.
7
The fasting glucose criteria was later changed to ≥ 100 mg/dL in
2004 based on definition of Impaired Fasting Glucose set by the American
Diabetes Association. The World Health Organization criteria for metabolic
syndrome differs to include elevated fasting insulin levels, glucose level of ≥200
mg/dL after a two hour oral glucose challenge test, and BMI ≥ 30kg/m
2
as an
alternative to waist circumference measurements. Each of the components of
the metabolic syndrome is a significant risk factor for cardiovascular disease and
diabetes, but the risk is even higher if metabolic syndrome is present.

While there are many conflicting studies regarding the diabetogenic and lipogenic
effects of progestin-only contraceptive methods, there is biologic plausibility that
while overall cholesterol production is not altered, apo-A-I-mediated HDL-C
assembly may be inhibited and thus HDL-C production can decrease while using
progestin-only contraceptive methods.
8
In normal weight women, this is unlikely
to be clinically significant. However, in obese women, decreasing HDL-C or
altering other markers of the metabolic syndrome may increase risk for long-term
cardiovascular and metabolic disease. While metabolic effects of long-acting
3
reversible contraceptive methods have not been specifically studied in obese
women, other women at high risk for diabetes have been studied with varying
results.
4

OBJECTIVE

The objective of this study is to determine if treatment with the levonorgestrel-
releasing intrauterine system (LNG-IUS) alters metabolic markers and
components of metabolic syndrome in obese women (BMI ≥ 30m
2
/kg) differently
than obese users of non-hormonal contraception (NHC) at 3 months after
initiation of use.
5
METHODS

Subjects
This study is a prospective cohort of obese women. Ten women between ages
18-39 years with BMI ≥30 kg/m
2
wishing to use LNG-IUS for contraception were
recruited for this study. An additional 10 subjects who were already using or
desired to use non-hormonal contraception were recruited as a control group.
The control group consisted of women who were already using a non-hormonal
intrauterine device, condoms or tubal ligation. All potential subjects were
screened to exclude those with diabetes, hypercholesterolemia, hypertension or
treatment for hypertension, cardiovascular disease, liver enzyme abnormalities,
clinical evidence of polycystic ovarian syndrome (PCOS) or any other
contraindications for the use of the LNG-IUS. Potential subjects were recruited
through the Reproductive Research Clinic of Los Angeles County + University of
Southern California Medical Center. All subjects signed informed consent upon
enrollment in the study.

Study Design
Once women meeting eligibility criteria were enrolled in the study, laboratory
assessment was performed at baseline and at 3 months after enrollment and will
be performed 6 months after enrollment. Subjects who desired to use LNG-IUS
for contraception, had the device inserted after the initial baseline laboratory
6
assessments were performed. Insertions were performed during days 1-5 of the
menstrual cycle or after having two negative urine pregnancy tests measured two
weeks apart if they had a history of oligomenorrhea. Subjects were instructed to
use barrier methods and/or abstinence for contraception during the two week
interval between urine pregnancy tests and for 7 days after insertion of the
device.

At each of these visits, components of metabolic syndrome were measured.
Measurements of weight, height, abdominal circumference, and blood pressure
were taken, and BMI was calculated at each of these visits. Subjects also
completed a questionnaire regarding diet and exercise at each of these visits to
assess that their habits have not changed during the study period. Fasting
glucose and fasting lipid panel were also measured at each visit. At the
completion of the six-month study period, one of the co-investigators will review
the results of the glucose and lipid tests for each subject and discuss the
importance of weight loss and lifestyle changes.

This study received approval from the USC Health Sciences Institutional Review
Board.

7
Statistical Analysis
Statistical assistance was obtained from the USC Keck School of Medicine
Department of Preventive Medicine and was analyzed using SAS Software.
Paired t-tests and ANOVA was used to evaluate categorical and continuous data
respectively, including baseline characteristics and outcome measures.
Descriptive variables were analyzed using chi-square (Fishers exact) and t-tests
for categorical and continuous variables, respectively. Statistical significance will
be considered for p-value <0.05.

The study was not powered to detect a statistically significant difference in
parameters of lipid profile, changes in blood pressure, waist circumference or
BMI. However, these variables will be analyzed and interpreted for clinical
significance. Clinical significance will be defined as: (1) Decrease in HDL-C by at
least 3 mg/dL, (2) increase in systolic blood pressure by 10 mm Hg or in diastolic
blood pressure by 5 mm Hg or more, (3) increase in fasting glucose by at least 5
mg/dL.
8
RESULTS

During the study period, 31 women were screened for participation in the study
and 9 women were determined to be ineligible based on inclusion and exclusion
criteria. Of the 22 participants that were recruited, 9 subjects desired to use the
LNG-IUS and 8 subjects desired to continue a method of non-hormonal
contraception. An additional 5 subjects desired to use another form of progestin-
only contraception and their results are not reported here. Of the 9 subjects who
received LNG-IUS and the 8 subjects who continued to use NHC, 6 subjects
from each group have completed their Month 3 visit as shown in Figure.
Additionally, 5 subjects of the LNG-IUS and 2 subjects of the NHC groups have
completed their Month 6 visit, but those results have not yet been analyzed.

Figure. Enrollment Flow Sheet
Assessed for
eligibility
n=31
Desired other progestin-
only method
n=5
Desired LNG-IUS
n=9
Completed 3
month visit
n=6
Desired NHC
n=8
Completed 3
month visit
n=6
Did not meet criteria (n=9)
Unable to comply with protocol n=4
Elevated AST/ALT n=3
Elevated HbA1c n=1
Clinical evidence of PCOS n=1
9
The demographic and baseline characteristics are shown in Table 1. There were
no statistically significant differences in age, parity, BMI, or history of gestational
diabetes. There were more African-American women that chose non-hormonal
methods of contraception compared to LNG-IUS, while more Hispanic women
chose to use the LNG-IUS (p=0.01 and p=0.02, respectively). Women who
chose to use non-hormonal contraception were also more likely to have a family
history of diabetes mellitus (75% vs 55%, p=0.04).

Table 1. Demographic and baseline characteristics of subjects
Characteristic NHC (n=8) LNG-IUS (n=9) p-value
Age* (years) 27 (19-36) 29.2 (18-36) 0.45
Parity* 1.2 (0-4) 1.5 (0-5) 0.71
BMI* (kg/m
2
) 39.1 (31.2-49.6) 37.4 (31.1-46.6) 0.58

Race/ethnicity
Hispanic
African-American
Other

50%
50%
0%

89%
0%
11%

0.02*
0.01*
Family History of DM 75% 55% 0.04*
Personal History of
GDM
0% 0% --
*Reported in means (range). DM=Diabetes Mellitus. GDM=Gestational diabetes.

Components of metabolic syndrome were compared at baseline were compared
between the two groups. Non-hormonal users had statistically significant higher
baseline systolic blood pressure compared to LNG-IUS users (p=0.03) while
LNG-IUS users had clinically significant higher triglycerides, although this was
not statistically significant (p=0.06) as shown in Table 2. The other components
10
of metabolic syndrome did not statistically or clinically differ between the two
groups.

Table 2. Mean value of components of metabolic syndrome at baseline by contraceptive group.
NHC (n=8) LNG-IUS (n=9) p-value
BMI (kg/m
2)
39.1 37.4 0.58
HDL-C (mg/dL) 47.6 50.8 0.60
Fasting glucose (mg/dL) 86.3 89.8 0.48
Abdominal
circumference (cm)
119 113 0.39
Triglycerides (mg/dL) 83.5 128.3 0.06
Systolic BP (mm Hg) 119 110 0.03*
Diastolic BP (mm Hg) 77 71 0.17
*p-value <0.05

Components of metabolic syndrome among all women completing both baseline
and Month 3 visit were analyzed to determine which parameters warranted
further analysis by contraceptive group as shown in Table 3. The mean change
of HDL-C and fasting glucose were both statistically significant and clinically
significant. Among all women, mean HDL-C decreased by 5.3 mg/dL (p=0.03)
and mean fasting glucose increased by 5.3 mg/dL (p=0.04). There was a
statistically significant mean increase in systolic blood pressure of 5.3 mm Hg
(p=0.03), although this was not considered clinically significant. There was no
clinically or statistically significant change of BMI, abdominal circumference, and
triglycerides.

11
Table 3. Mean change in components of metabolic syndrome among ALL women.
Mean Change p-value
BMI (kg/m
2)
-0.2 0.91
HDL-C (mg/dL) -5.3 0.03*
Fasting glucose (mg/dL) 5.3 0.04*
Abdominal circumference (cm) 0.07 0.93
Triglycerides (mg/dL) -0.67 0.9
Systolic BP (mm Hg) 5.3 0.03*
Diastolic BP (mm Hg) 6.5 0.36
*p-value <0.05.

The three components of metabolic syndrome that had a statistically significant
change from baseline were HDL-C, fasting glucose and systolic blood pressure.
Changes of these three components were analyzed between the two groups as
shown in Table 4. Although the LNG-IUS group had a clinically significant mean
decrease in HDL-C of 8.5 mg/dL and mean increase in fasting glucose of 10.7
mg/dL from baseline to month 3 visit, these values were marginally significantly
different from the NHC group. The mean increase in systolic blood pressure in
both groups was not considered to be clinically significant or statistically
significant.

Table 4. Mean change of components of metabolic syndrome by contraceptive group.
NHC (n=6) LNG-IUS (n=6) p-value
HDL-C (mg/dL) 0.5 -8.5 0.06
Fasting glucose (mg/dL) 1.7 10.7 0.09
Systolic BP (mm Hg) 6.5 4.5 0.69

12
DISCUSSION

The obesity epidemic among reproductive age women in the United States
necessitates that contraceptives be studied in this population. Due to the
increased risk associated with pregnancy, obese women are often counseled to
use long-acting, very effective methods of contraception. It is important that
these methods do not increase their already elevated risk for cardiovascular and
metabolic disease. Previous research suggests that progestin-only contraception
decreases HDL cholesterol.
8
While a small decline in HDL-C may not affect the
long-term risks for normal weight women, this may have a more profound clinical
impact in obese women (BMI ≥30 kg/m
2
).

Plasma levels of levonorgestrel from the levonorgestrel-releasing intrauterine
system (LNG-IUS) reach approximately 5% (0.15 – 0.2 ng/mL) of values
following ingestion of a 150 mcg dose of oral levonorgestrel (0.8-3.6 ng/mL),
resulting in minimal systemic effects.
9
In one study of 48 women (mean age of
44 years) using LNG-IUS for the treatment of menorrhagia, there was a mean
decrease in diastolic blood pressure with no significant change in systolic blood
pressure, lipid profile, or liver function tests. While mean fasting blood glucose
increased, the 5 women that had elevated fasting blood glucose (>110mg/dL) at
1-year follow-up, all had fasting blood glucose levels of 100-105 mg/dL at
baseline.
10
In the absence of a control group, it is unclear if the IUD had any
13
effect on their predestined changes in glucose levels. While this study
demonstrated stable lipid profiles, another study reported a decline in HDL-C in
LNG-IUS users compared with CuT380 users at 6 months that resolved over
time.
11
In a randomized study comparing the CuT380 and LNG-IUS in women
with diabetes, fasting glucose, hemoglobin A1c (HbA1c), and insulin
requirements did not change after insertion of either device.
12

This study investigated changes in components of metabolic syndrome among
obese women. We found that there was a clinically significant decrease in HDL-
C and increase in fasting glucose among obese women during the first three
months of use in those using LNG-IUS compared to the control group of obese
women using non-hormonal contraception. When all women were analyzed
together to evaluate which parameters were affected, there was a statistically
significant decrease in HDL-C, increase in fasting glucose and increase in
systolic blood pressure. However, these changes did not continue to be
statistically significant when compared between the two groups, although they
continued to have clinical significance as defined in the study design. Since it
has been shown that increasing HDL-C levels even by as little as 1mg/dL has
significant improvement in reducing cardiovascular risk by 2-3%
13
, this amount of
decline in HDL-C levels may be concerning if it does persist over time.

14
The limitations of this study are its small sample size. Baseline characteristics
were overall fairly similar between the two groups, with the exception of race and
family history of diabetes. The non-hormonal users were more likely to be
African-American and more likely to have a family history of diabetes. This may
influence how progestin-only methods influence changes in fasting glucose,
however, there was not a statistically significant difference in fasting glucose
levels at baseline among the two groups. However, this difference in family
history between the two groups may have caused fasting glucose levels to be
greater among the non-hormonal group compared to the LNG-IUS group, which
was not demonstrated in our analysis of outcomes at Month 3. Another limitation
is the short follow-up of this study. Serum levels of levonorgestrel in users of the
LNG-IUS are higher immediately after insertion and reach steady state without
peaks and troughs after the first few weeks.
14
Additionally, normal weight users
of the LNG-IUS have previously been shown to have a transient decrease in
HDL-C of 3.5mg/dL that resolved by one year
11
and that may be shown in the
continued follow-up of these obese subjects, as well.

This study illustrates that obese women may have different metabolic responses
to progestin-only contraception than non-obese women. As the obesity epidemic
continues to grow, it will become increasing important to be able to counsel and
offer women reliable contraception that does not increase their risk of
cardiovascular and metabolic disease
15
REFERENCES

Back DJ, Bates M, Breckenridge AM, Hall JM, Mac Iver M, Oreme MLE, Park
BK, Row PH. The pharmacokinetics of levonorgestrel and ethynlestradiol in
women – studies with Ovran and Ovranette. Contraception 1981;23(3):229-239.
[9]

Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for
Contraceptive Use, 2010. MMWR Early Release May 28,2010:59. [5]

Center for Disease Control and Prevention. U.S. Obesity Trends 1985-2008
http://www.cdc.gov/nccdphp/dnpa/obesity/trend.html. Accessed June 8, 2009.
[1]

Executive Summary of the Third Report of the National Cholesterol Education
Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III.) JAMA 2001; 285 (19):
2586-2497. [6]

Grundy S, Cleeman J, Daniels S, et al. Diagnosis and Management of the
Metabolic Syndrome: An American Heart Association/ National Heart, Lung, and
Blood Institute Scientific Statement. Circulation 2005; 112: 2735-2752. [7]

Kayikcioglu F, Gunes M, Ozdegirmenci O, Haberal A. Effects of levonorgestrel-
releasing intrauterine system on glucose and lipid metabolism: a 1-year follow-up
study. Contraception. 2006 May;73(5):528-31. [10]

Knopp R. Risk Factors for coronary artery disease in women. American Journal
of Cardiology 2002; 89(suppl):28E-35E. [13]

Kojima K, Abe-Dohmae S, Arakawa R, Murakami I, Suzumori K, Yokoyama S.
Progesterone inhibits apolipoprotein-mediated cellular lipid release: A putative
mechanism for the decrease of high-density lipoprotein. Biochemica et
Biophysica Acta 2001; 1532: 173-184. [8]

Mirena Full Prescribing Information. Bayer Pharmaceuticals. Clinical
Pharmacology, Section 12.3 Pharmacokinetics. Updated October 2009 [14]
16
Ng Ying Woo, Liang S, and Singh K. Effects of Mirena (levonorgesterl-releasing
intrauterine system) and Ortho Gynae T380 intrauterine coper device on lipid
metabolism- a randomized comparative study. Contraption 2009; 79: 24-28. [11]

Rogovskaya S, Rivera R, Grimes DA, Chen PL, Pierre-Louis B, Prilepskaya V, et
al. Effect of a levonorgestrel intrauterine system on women with type 1 diabetes:
a randomized trial. Obstet Gynecol. 2005 Apr;105(4):811-5. [12]

Royal College of Obstetricians and Gynaecologist. Venous Thromboembolism
and Hormonal Contraception Guideline No 40. October 2004. [3]

Siega-Riz, AM, Laraia B. The implications of maternal overweight and obesity on
the course of pregnancy and birth outcomes. Maternal & Child Health Journal
2006; 10: S153-156. [2]

WHO World Health Organization. Medical Eligibility for Contraceptive Use: 2008
Update. http://whglibdoc.who.int/hg/2008/WHO_RHR_08.19_eng.pdf. Accessed
December 3, 2009. [4]

Abstract (if available)

Abstract Background: The obesity epidemic among reproductive age women in the United States necessitates that contraceptives be studied in this population given the need for effective long-acting contraception that does not increase their already elevated risk for cardiovascular and metabolic disease. Previous research suggests that progestin-only contraception may decrease HDL-C cholesterol. While a small decline in HDL-C may not affect the long-term risks for normal weight women, this may have a more profound clinical impact in obese women (BMI ≥30 kg/m2). The metabolic effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) have been studied in normal weight women, but not in obese women.

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Asset Metadata

Creator Bender, Nicole Mosteller (author)

Core Title Effects of progestin-only long-acting reversible contraception on metabolic markers in obese women

School Keck School of Medicine

Degree Master of Science

Degree Program Preventive Medicine (Health Behavior)

Degree Conferral Date 2011-05

Publication Date 04/13/2011

Defense Date 03/29/2011

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag contraception,metabolic effects,OAI-PMH Harvest,obesity

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Azen, Stanley Paul (committee chair), Mishell, Daniel R., Jr. (committee member), Stanczyk, Frank Z. (committee member)

Creator Email mostelle@usc.edu,nmbender@gmail.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-m3746

Unique identifier UC1280635

Identifier etd-Bender-4519 (filename),usctheses-m40 (legacy collection record id),usctheses-c127-441514 (legacy record id),usctheses-m3746 (legacy record id)

Legacy Identifier etd-Bender-4519.pdf

Dmrecord 441514

Document Type Thesis

Rights Bender, Nicole Mosteller

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Repository Name Libraries, University of Southern California

Repository Location Los Angeles, California

Repository Email cisadmin@lib.usc.edu