Race, Menopause and Metabolism After Exercise and Diet

NCT00882141 | Completed DMC

• 3 other identifiers: AG0116R01AG019310R01AG020116
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Insulin Resistance; Sedentary Lifestyle

Keywords

Exercise; Obesity; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

• Glucose Clamp

  At 4-6 weeks

• Fat biopsy

  At 4-6 weeks

Study Arms (2)

1

EXPERIMENTAL

Weight loss

Behavioral: Diet modification

2

EXPERIMENTAL

Exercise plus weight loss

Behavioral: Diet modification; Behavioral: Aerobic exercise

Interventions

Diet modification BEHAVIORAL

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

Also known as: American Heart Association "Heart Healthy" diet

1; 2

Aerobic exercise BEHAVIORAL

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

2

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

University of Maryland, VAMC

Baltimore, Maryland, 20705, United States

Location

Related Publications (11)

• Berman DM, Rodrigues LM, Nicklas BJ, Ryan AS, Dennis KE, Goldberg AP. Racial disparities in metabolism, central obesity, and sex hormone-binding globulin in postmenopausal women. J Clin Endocrinol Metab. 2001 Jan;86(1):97-103. doi: 10.1210/jcem.86.1.7147.

  PMID: 11231984 BACKGROUND

• Ryan AS, Nicklas BJ, Berman DM. Racial differences in insulin resistance and mid-thigh fat deposition in postmenopausal women. Obes Res. 2002 May;10(5):336-44. doi: 10.1038/oby.2002.47.

  PMID: 12006632 BACKGROUND

• Nicklas BJ, Dennis KE, Berman DM, Sorkin J, Ryan AS, Goldberg AP. Lifestyle intervention of hypocaloric dieting and walking reduces abdominal obesity and improves coronary heart disease risk factors in obese, postmenopausal, African-American and Caucasian women. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):181-9. doi: 10.1093/gerona/58.2.m181.

  PMID: 12586858 BACKGROUND

• Ryan AS, Nicklas BJ, Berman DM. Aerobic exercise is necessary to improve glucose utilization with moderate weight loss in women. Obesity (Silver Spring). 2006 Jun;14(6):1064-72. doi: 10.1038/oby.2006.122.

  PMID: 16861612 BACKGROUND

• Ryan AS, Serra MC, Goldberg AP. Metabolic Benefits of Prior Weight Loss with and without Exercise on Subsequent 6-Month Weight Regain. Obesity (Silver Spring). 2018 Jan;26(1):37-44. doi: 10.1002/oby.22032. Epub 2017 Oct 25.

  PMID: 29071802 DERIVED

• Ortmeyer HK, Goldberg AP, Ryan AS. Exercise with weight loss improves adipose tissue and skeletal muscle markers of fatty acid metabolism in postmenopausal women. Obesity (Silver Spring). 2017 Jul;25(7):1246-1253. doi: 10.1002/oby.21877. Epub 2017 May 26.

  PMID: 28547918 DERIVED

• Ge S, Ryan AS. Zinc-alpha2-glycoprotein expression in adipose tissue of obese postmenopausal women before and after weight loss and exercise + weight loss. Metabolism. 2014 Aug;63(8):995-9. doi: 10.1016/j.metabol.2014.04.013. Epub 2014 May 4.

  PMID: 24929893 DERIVED

• Ryan AS, Ge S, Blumenthal JB, Serra MC, Prior SJ, Goldberg AP. Aerobic exercise and weight loss reduce vascular markers of inflammation and improve insulin sensitivity in obese women. J Am Geriatr Soc. 2014 Apr;62(4):607-14. doi: 10.1111/jgs.12749. Epub 2014 Mar 17.

  PMID: 24635342 DERIVED

• Prior SJ, Blumenthal JB, Katzel LI, Goldberg AP, Ryan AS. Increased skeletal muscle capillarization after aerobic exercise training and weight loss improves insulin sensitivity in adults with IGT. Diabetes Care. 2014 May;37(5):1469-75. doi: 10.2337/dc13-2358. Epub 2014 Mar 4.

  PMID: 24595633 DERIVED

• Yang RZ, Blumenthal JB, Glynn NM, Lee MJ, Goldberg AP, Gong DW, Ryan AS. Decrease of circulating SAA is correlated with reduction of abdominal SAA secretion during weight loss. Obesity (Silver Spring). 2014 Apr;22(4):1085-90. doi: 10.1002/oby.20657. Epub 2013 Dec 6.

  PMID: 24311467 DERIVED

• Ryan AS, Li G, Blumenthal JB, Ortmeyer HK. Aerobic exercise + weight loss decreases skeletal muscle myostatin expression and improves insulin sensitivity in older adults. Obesity (Silver Spring). 2013 Jul;21(7):1350-6. doi: 10.1002/oby.20216. Epub 2013 May 19.

  PMID: 23687104 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance; Sedentary Behavior; Motor Activity

Interventions

Diet Therapy; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alice S. Ryan, PhD

  University of Maryland, VA Research Service

  PRINCIPAL INVESTIGATOR

• Andrew P. Goldberg, MD

  University of Maryland, VA Research Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: March 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (1)