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Completed

NCT Number: NCT01457703

Reproductive Hormonal Alterations in Obesity

The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined.

--Hypotheses:

1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Translational Research Center

Aurora, Colorado, 80045, United States

About this study

AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-40 at study entry
  • BMI either 18-25 kg/m2 or ≥30 kg/m2
  • prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
  • Baseline hemoglobin >11 gm/dl
  • History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2
  • History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2

Exclusion criteria

  • History of chronic disease affecting hormone production, metabolism or clearance
  • Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)
  • Use of hormones within three months of enrollment
  • Excessive exercise (>4 hours per week)
  • Pregnancy, breast-feeding or current active attempts to conceive

Treatment and study plan

Cetrorelix

Drug

Abolishes pituitary sensitivity to GnRH.

Other names: Cetrotide

Gonadorelin-GnRH

Drug

GnRH is used to stimulate the pituitary gland to produce LH and FSH.

Other names: Lutrepulse

Recombinant LH

Drug

Used to stimulate ovarian function in women.

Other names: Luveris

letrozole

Drug

An aromatase inhibitor.

Other names: Femara

Primary outcomes

  1. Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)

    Time frame: Measured hourly and averaged over the 12 hour study visit

    Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.

  2. Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)

    Time frame: Measured hourly and averaged over the 12 hour study visit

    Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.

  3. Changes in Pregnanediol Glucuronide (PdG) (Aim 2)

    Time frame: Averaged over the length of menstrual cycle

    Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.

Secondary outcomes

  1. Changes in Follicle Stimulating Hormone (FSH) (Aim 1)

    Time frame: Measured hourly and averaged over the 12 hour study visit

    Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.

  2. Changes in Follicle Stimulating Hormone (FSH) (Aim 2)

    Time frame: Measured hourly and averaged over the 12 hour study visit

    Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Reproductive Hormonal Alterations in Obesity, AIMS #1 & #2

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2011
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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