Metabolic Syndrome Clinical Trial
— DEMOOfficial title:
Diet, Exercise, Metabolism, and Obesity in Older Women:DEMO
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Reductions in fat oxidation and resting metabolic rate (RMR) are associated with normal aging and are accelerated with menopause. As a result, postmenopausal women have an increased risk of abdominal obesity and ultimately the metabolic complications that lead to the insulin resistance syndrome and its associated risks (hyperlipidemia, type 2 diabetes, and coronary heart disease). Thus, there is a need to determine the most successful treatment to reduce visceral obesity in postmenopausal women. The purpose of this study is to determine if dietary-induced weight loss alone and/or weight loss combined with exercise at low and high- intensities differentially affect the reduction in visceral adipose tissue in postmenopausal women with abdominal obesity.
Status | Completed |
Enrollment | 112 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Currently 50 - 70 years of age (at screening) - Post-menopausal at least 1 year - Waist diameter of at least 34" - Able to attend exercise classes 3 times per week - BMI between 25 & 40 kg/m2 - MMSE > 25 Exclusion Criteria: - Exercises regularly (ie- more than twice a week for more than 15 minutes per session)? - Uncontrolled diabetes mellitus or insulin-controlled diabetes? - Does not drive and does not have a reliable way to pick up meals once a week - Cancer in past 5 years except skin cancer - Unwilling or unable to eat prepared foods (non-compliant during test week) - Unwilling or unable to record food intake accurately - Self-reported weight loss or gain >5% in past 6 months - Smoking within past year, or use of tobacco or nicotine product - Coronary artery disease, liver disease, renal disease, or other systemic disorders - Pulmonary disease - Current use of thiazide diuretics, beta blockers or steroids - Current use of more than one anti-hypertensive medication - Current use of anti-depressants or hormone replacement therapy - Gross physical impairment - Blindness or retinopathy - Triglyceride level >400 mg/dl - Anemia (Hct < 37%) - Contraindication to exercise by ECG or GXT |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Institute on Aging (NIA) |
United States,
You T, Murphy KM, Lyles MF, Demons JL, Lenchik L, Nicklas BJ. Addition of aerobic exercise to dietary weight loss preferentially reduces abdominal adipocyte size. Int J Obes (Lond). 2006 Aug;30(8):1211-6. Epub 2006 Jan 31. — View Citation
You T, Yang R, Lyles MF, Gong D, Nicklas BJ. Abdominal adipose tissue cytokine gene expression: relationship to obesity and metabolic risk factors. Am J Physiol Endocrinol Metab. 2005 Apr;288(4):E741-7. Epub 2004 Nov 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abdominal visceral fat volume | Baseline, follow-up | ||
Secondary | HDL cholesterol Triglyceride concentrations Glucose tolerance | Baseline and Follow-up |
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