Genetics, Metabolism and Weight Loss in Older, Obese Veterans

Obesity Clinical Trial

Official title:

Genetics, Metabolism and Weight Loss in Older, Obese Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018330
• Other study ID #: AGCG-006-98F
• Status: Completed
• Phase: N/A
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: April 1999
• Est. completion date: March 2004

Study information

• Verified date: December 2004
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine whether sequence variation in the lipoprotein lipase (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary veterans.

Description:

Veterans who are 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. Exclusion criteria are: diabetes, hypertriglyceridemia (>400 mg/dl), history of cancer or myocardial infarction, clinical depression, renal, liver or hematologic disease, and medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers). Changes in total and visceral body fat are measured by dual x-ray absorptiometry and computerized tomography, resting energy expenditure and fat oxidation rate by indirect calorimetry, and lipoprotein lipids by enzymatic assay. Glucose tolerance is assessed during a three-hour oral glucose tolerance test with measurement of glucose- and insulin levels every 30 minutes. LPL activity is measured in 3050mg pieces of subcutaneous abdominal and gluteal adipose tissue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

• 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam.

Exclusion criteria:

• Diabetes,

• Hypertriglyceridemia (>400 mg/dl),

• History of cancer or myocardial infarction,

• Clinical depression,

• Renal, liver or hematologic disease, and

• Medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Weight Loss

Locations

Country	Name	City	State
United States	VA Maryland Health Care System	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,