Females, Aging, Metabolism, and Exercise (FAME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01712230
First received: October 19, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Obesity
Drug: GnRH agonist
Behavioral: Supervised cardiovascular exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Physical activity energy expenditure (PAEE) [ Time Frame: Change from baseline to 3 and 6 months ] [ Designated as safety issue: No ]
    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 (measured by indirect calorimetry).


Secondary Outcome Measures:
  • Total energy expenditure, sleeping EE, thermic effect of feeding, body composition, energy intake [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Monthly placebo injections for 6 months
Active Comparator: GnRH agonist
Monthly GnRH agonist injections for 6 months
Drug: GnRH agonist

Drug: leuprolide acetate

Other Names:

Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months

Other Name: Leuprolide Acetate 3.75mg
Active Comparator: GnRH agonist + exercise
Monthly GnRH agonist injections for 6 months plus supervised exercise intervention
Drug: GnRH agonist

Drug: leuprolide acetate

Other Names:

Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months

Other Name: Leuprolide Acetate 3.75mg
Behavioral: Supervised cardiovascular exercise
Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months

Detailed Description:

Participants will be women who are nearing menopause based on age (42-52 y) but have normal menstrual cycles. Participants will be randomized to receive monthly injections of placebo or a study drug that reduces sex hormones (GnRH agonist) for 24 weeks. Women who receive GnRH agonist will be further randomized to no exercise or a supervised exercise program. Thus, the 3 treatment groups are: placebo, GnRH agonist, GnRH agonist+exercise. The investigators will measure changes in calories burned during physical activity, sleep, rest, and after a meal after 3 and 6 months of hormone suppression using doubly-labeled water and room calorimetry. Other measures include food intake estimated from food records; body composition measured by dual-energy x-ray absorptiometry (DXA); glucose and insulin responses to an oral glucose tolerance test; and markers of inflammation in the blood.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Volunteers will be healthy women aged 40 to 60 years who are still experiencing regular menstrual cycles. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks and physically able to be randomized to participate in a programmed exercise training program. We will consent up to 132 subjects with the aim of enrolling 22 in each of the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise).

Exclusion Criteria:

  • 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
  • BMI <40 kg/m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712230

Contacts
Contact: Kim Harner, MS 720-848-6399 kimberly.harner@ucdenver.edu
Contact: Ellie Gibbons, BA 720-848-6408 ellie.gibbons@ucdenver.edu

Locations
United States, Colorado
University of Colorado - Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Wendy M Kohrt, PhD         
Sub-Investigator: Rachael VanPelt, PhD         
Sub-Investigator: Edward Melanson, PhD         
Sub-Investigator: Karen Villalon, MD         
Sub-Investigator: Daniel Bessesen, MD         
Sub-Investigator: David Weitzenkamp, PhD         
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01712230     History of Changes
Other Study ID Numbers: 12-1157, P50HD073063
Study First Received: October 19, 2012
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
hormone therapy
obesity
menopause
disease /disorder proneness /risk
insulin sensitivity /resistance
metabolic syndrome
women's health

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Deslorelin
Leuprolide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014