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Clinical Trials/NCT00141076
NCT00141076
Completed
Not Applicable

Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2

Boston Children's Hospital1 site in 1 country24 target enrollmentOctober 2003
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Boston Children's Hospital
Enrollment
24
Locations
1
Primary Endpoint
Insulin sensitivity as measured by FS-IVGTT
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day crossover feeding trial.

Detailed Description

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese male adults in a 10-day crossover feeding trial. Hypothesis: Obese subjects will show improvements in clinical endpoints associated with risk for diabetes and cardiovascular disease (CVD) after consuming a controlled low (compared to high) glycemic index diet for 10 days. 1º endpoint: insulin sensitivity as measured by the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT). 2º endpoints: CVD risk factors; postprandial studies of oxidative stress; thermic effect of food.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
July 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • age 18 to 35 years
  • BMI ≥ 27 ≤45 kg/m2
  • willingness to refrain from alcohol and caffeinated beverage consumption for duration of study

Exclusion Criteria

  • major medical illness
  • an abnormal screening laboratory test
  • taking any prescription medications that might affect body weight
  • current smoking (1 cigarette during any of the last 7 days)
  • consuming special diets

Outcomes

Primary Outcomes

Insulin sensitivity as measured by FS-IVGTT

Secondary Outcomes

  • CVD risk factors
  • Postprandial studies of oxidative stress
  • Thermic effect of food

Study Sites (1)

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