Race, Menopause and Metabolism After Exercise and Diet

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00882141
First received: April 15, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
Sedentary Lifestyle
Behavioral: Diet modification
Behavioral: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Menopause, Genes and Metabolism After Weight Loss and Exercise

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Glucose Clamp [ Time Frame: At 4-6 weeks ] [ Designated as safety issue: No ]
  • Fat biopsy [ Time Frame: At 4-6 weeks ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: March 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00882141

Locations
United States, Maryland
University of Maryland, VAMC
Baltimore, Maryland, United States, 20705
Sponsors and Collaborators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice S. Ryan, Ph.D., University of Maryland School of Medicine
ClinicalTrials.gov Identifier: NCT00882141     History of Changes
Other Study ID Numbers: AG0116, RO1 AG19310, R01 AG20116
Study First Received: April 15, 2009
Last Updated: January 11, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Exercise
Obesity
Insulin Sensitivity

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Body Weight
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014