Females, Aging, Metabolism, and Exercise

NCT01712230 | Completed Results

• 2 other identifiers: 12-1157P50HD073063
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine whether a reduction in hormones (such as occurs during menopause) causes a decrease in calories burned during physical activity. This study will also determine whether a reduction in hormones decreases calories burned while sleeping, resting, and eating and whether an exercise intervention can prevent this.

Conditions

Obesity

Keywords

hormone therapy; obesity; menopause; disease /disorder proneness /risk; insulin sensitivity /resistance; metabolic syndrome; women's health

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity Energy Expenditure (PAEE)

  PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).

  Change from baseline to 6 months

Secondary Outcomes (2)

• Total Fat Mass

  Change over 6 months

• Total Fat Free Mass

  Change over 6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Monthly placebo injections for 6 months

Drug: Placebo

GnRH agonist

ACTIVE COMPARATOR

Monthly GnRH agonist injections for 6 months

Drug: GnRH agonist

GnRH agonist + exercise

ACTIVE COMPARATOR

Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention

Drug: GnRH agonist; Behavioral: Supervised cardiovascular exercise

Interventions

GnRH agonist DRUG

Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months

Also known as: Leuprolide Acetate 3.75mg

GnRH agonist; GnRH agonist + exercise

Supervised cardiovascular exercise BEHAVIORAL

Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months

GnRH agonist + exercise

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 40 to 60 years
• Are still experiencing regular menstrual cycles.
• They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks
• Be physically able to be randomized to participate in a programmed exercise training program.
• The investigators will consent up to 132 subjects with the aim of enrolling 22 in each of the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise).

You may not qualify if:

• irregular menstrual cycles defined as 2 or more missed cycles in the previous year
• serum FSH \>25 mIU/mL measured during the first 5 days of the menstrual cycle
• on hormonal contraceptive or menopausal therapy
• positive pregnancy test
• intention to become pregnant or start hormonal contraceptive therapy during the period of study
• lactation
• known hypersensitivity to GnRH or leuprolide acetate
• score \>16 on the CESD((Center for Epidemiologic Studies Depression Scale )
• severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores \< -2.0)
• abnormal vaginal bleeding
• thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
• uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications
• cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist
• orthopedic or other problems that would interfere with participation in the exercise program
• exercising at least 30 minutes per day at a moderate to vigorous intensity most days of the week (defined as \>4 d/wk) over the past 6 months

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Gavin KM, Melanson EL, Hildreth KL, Gibbons E, Bessesen DH, Kohrt WM. A Randomized Controlled Trial of Ovarian Suppression in Premenopausal Women: No Change in Free-Living Energy Expenditure. Obesity (Silver Spring). 2020 Nov;28(11):2125-2133. doi: 10.1002/oby.22978.

  PMID: 33150745 DERIVED

MeSH Terms

Conditions

Obesity; Disease Susceptibility; Metabolic Syndrome

Interventions

Gonadotropin-Releasing Hormone; Leuprolide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

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: Wendy Kohrt, PhD
• Organization: University of Colorado Anschutz Medical Campus

Wendy.Kohrt@CUAnschutz.edu

303-724-1913

Study Officials

• Wendy Kohrt, PhD

  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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-11

Locations

US (1)