Race, Menopause and Metabolism After Exercise and Diet

January 11, 2010 updated by: National Institute on Aging (NIA)

Menopause, Genes and Metabolism After Weight Loss and Exercise

The purpose of this study is to test the hypotheses that there are ethnic and genetic differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in overweight, insulin resistant postmenopausal women. This will be tested in a trial comparing the effects of weight loss vs. aerobic exercise plus weight loss on glucose, lipid, fat and muscle metabolism in overweight African American and Caucasian postmenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The findings of this study will also determine whether there are racial differences in the whole body and cellular mechanisms by which aerobic exercise training and weight loss affect glucose, lipid, fat and muscle metabolism in African-American vs. Caucasian postmenopausal women. The results also may provide a rationale for targeting specific populations of women who might improve glucose, lipid, fat and muscle metabolism more from the addition of exercise to dietary restriction than weight loss alone to reduce their risk for type 2 diabetes and cardiovascular disease.

The study protocol consists of the following phases:

Phase 1-Recruitment and screening.

Phase 2-Weight and dietary stabilization for 4-6 weeks, where participants are taught the principles of the American Heart Association "Heart Healthy" diet and provided food to consume prior to testing.

Phase 3-Participants will undergo research testing including glucose clamp and fat biopsy.

Phase 4-Participants select either weight loss only, or exercise plus weight loss. The behavior diet modification weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months where the recommended caloric intake for each participant is adjusted by the dietitian to elicit a weight loss of approximately 0.2-0.4 kg per week. In addition to the weight loss sessions, participants who select the aerobic exercise plus weight loss intervention will exercise at the Baltimore Geriatric Research Education and Clinical Center (GRECC) exercise facility 3 times a week for 6-9 months using treadmills and other aerobic exercise equipment. Exercise sessions begin at low levels of VO2max (maximal oxygen consumption) and progress in duration and intensity until the participant is able to exercise at more than 75% VO2max for 45 minutes.

Phase 5-Following the 6-9 months of long-term weight loss or exercise plus weight loss, all participants will undergo long-term metabolic testing.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 20705
        • University of Maryland, VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • 45-80 yrs of age
  • Non-smoking for one year
  • BMI greater than 25 kg/m2 and less than 50 kg/m2
  • Menopause over 1 year
  • Caucasian or African American ethnicity

Exclusion Criteria:

Both groups

  • Currently being treated for active cancer
  • Type 1 diabetes; insulin treatment; poorly controlled (fasting blood sugar over 160 mg/dl)
  • Allergic to lidocaine or heparin
  • Untreated dyslipidemia, receiving triglyceride-lowering meds
  • Other systemic disorders that are not medically treated and stable
  • Taking beta-blockers, oral steroids, warfarin or any other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
  • Abnormal liver or renal function; chronic pulmonary disease (on supplemental oxygen); anemia
  • MMSE (Mini-Mental State Examination) below 24, dementia or unstable clinical depression by exam
  • Women of ethnicity other than Caucasian or African American
  • Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension unless medically stabilized
  • Abnormal response to exercise test (chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising blood pressure above 240/120mm Hg, or other contraindications to exercise)

Exercise plus weight loss group only

  • Medical history of CVD (cardiovascular disease) with symptoms limiting ability to exercise
  • Physical impairment limiting normal activity
  • Aerobically trained with VO2max greater than 2 SD (standard deviation) above age-adjusted mean

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Weight loss
Behavioral: Diet modification
Weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months; recommended caloric intake to elicit a weight loss of approximately 0.2-0.4 kg per week
Other Names:
  • American Heart Association "Heart Healthy" diet
Experimental: 2
Exercise plus weight loss
Behavioral: Diet modification
Weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months; recommended caloric intake to elicit a weight loss of approximately 0.2-0.4 kg per week
Other Names:
  • American Heart Association "Heart Healthy" diet
Behavioral: Aerobic exercise
Treadmills and other aerobic exercise equipment 3 times a week for 6-9 months, beginning at low levels of VO2max and progressing in duration and intensity to more than 75% VO2max for 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose Clamp
Time Frame: At 4-6 weeks
At 4-6 weeks
Fat biopsy
Time Frame: At 4-6 weeks
At 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Alice S. Ryan, PhD, University of Maryland, VA Research Service
  • Principal Investigator: Andrew P. Goldberg, MD, University of Maryland, VA Research Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0116
  • R01AG019310 (U.S. NIH Grant/Contract)
  • R01AG020116 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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