Brown Adipose Tissue Activity in Pre- and Postmenopausal Women

NCT02927392 | Completed Results

• 2 other identifiers: 16-14791R01DK112260-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown. The investigators have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). The investigators preliminary data suggest that this may be due, in part, to reduced brown adipose tissue (BAT) activity. The overarching hypothesis is that BAT activity in humans is modulated by E2. To determine if natural declines in endogenous E2 contribute to changes in BAT activity, we will compare BAT activity in pre-and post-menopausal women. The investigators will also explore whether suppression of ovarian hormones in pre-menopausal women impairs BAT activity. BAT activity will be quantified using dynamic positron emission topography/computed tomography (PET/CT) imaging combined with 11C-acetate tracers. We will assess the thermogenic response of BAT by measuring cold-induced changes in REE, shivering, and skin and core temperature.

Conditions

Menopause; Obesity

Outcome Measures

Primary Outcomes (3)

• Brown Adipose Tissue Volume

  Brown adipose tissue volume will be measured using the radioactive tracer 18Fluro-deoxyglucose.

  5-6 hrs

• Brown Adipose Tissue Activity -Warm Exposure

  Brown adipose tissue activity in warm temperatures will be measured using the radioactive tracer 11C-acetate

  5-6 hrs

• Brown Adipose Tissue Activity - ColdExposure

  Brown adipose tissue activity after cold exposure will be measured using the radioactive tracer 11C-acetate

  5-6 hrs

Secondary Outcomes (2)

• Resting Energy Expenditure - Before Cold Exposure

  5-6 hrs.

• Resting Energy Expenditure - After Cold Exposure

  5-6 hrs

Study Arms (2)

Pre-menopausal women

EXPERIMENTAL

To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.

Drug: Leuprolide acetate

Post-menopausal women

NO INTERVENTION

To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.

Interventions

Leuprolide acetate DRUG

A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).

Also known as: Lupron

Pre-menopausal women

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal volunteers will be healthy, eumenorrheic women, aged 18-45 yrs. Eumenorrheic status will be verified by regular menses (no missed cycles in previous year; cycle length 25-35 d).
• Postmenopausal volunteers will be healthy women who have no menses for at least 12 months

You may not qualify if:

• \- Body mass index (BMI) \> 35 kg/m2
• Hormonal contraceptive use (past 6 mo.)
• Pregnant, lactating or intention to become pregnant during the period of study
• History or current use of hormonal replacement therapy (HRT)
• Women who have undergone surgical menopause.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Ottawa: collaborator
• Université de Sherbrooke: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Edward L. Melanson, PhD
• Organization: University of Colorado Anschutz Medical Campus

ed.melanson@cuanschutz.edu

303-724-0935

Study Officials

• Edward Melanson, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 7, 2016
• Study Start: March 16, 2017
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)