Overview

This trial is active, not recruiting.

Condition obesity
Treatments high caloric intake, reduced caloric intake
Sponsor Temple University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date August 2014
End date July 2016
Trial size 1 participant
Trial identifier NCT02505958, 22331, R01DK090588

Summary

Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin resistance produced by several days of overnutrition. Approach: Healthy volunteers will be admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic clamp study to assess their insulin resistance. Subjects will then start on an overnutrition program for 4 days consisting of 3 meals and 3 snacks containing ~6,000 Kcal/24hours. A second clamp study will be performed on day 5 to demonstrate the overnutrition induced increase in insulin resistance. Starting on day 5 the subject's caloric intake will be reduced to ~1,000 Kcal for 2 days (day 5 and 6). After that on the morning of day 7, a third hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric intake did reduce insulin resistance and the volunteer will be discharged from the Clinical Research Center.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking open label
Arm
(Other)
Volunteers will receive 3 meals and 3 snacks over a 24 hour period which will contain ~ 6,000 calories. Main meals will consist of ~ 1,500 calories and snacks will contain ~ 500 calories.
high caloric intake
Volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h.
(Other)
On days 5 and 6 subjects will receive 3 meals only and each meal will contain ~ 333 calories for a total of 1,000/ 24 hours.
reduced caloric intake
On days 5 and 6, volunteers will received 3 meals (~333 calories each) totaling ~ 1,000 calories/24 hours.

Primary Outcomes

Measure
Changes in insulin resistance
time frame: baseline, day 4 and day 7
Changes in oxidative stress
time frame: baseline, day1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in energy expenditure
time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in weight
time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in body composition
time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

Secondary Outcomes

Measure
Changes in blood glucose levels
time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in blood levels of insulin
time frame: Baseline, day1 day2, day 3, day 4, day 5, day 6, day 7
Changes in blood levels of free fatty acids
time frame: Baseline, day1 , day 2, day 3, day 4, day 5, day 6, day 7
Changes in blood ketone levels
time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in glucagon levels
time frame: bsaseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: Healthy non-obese men and women - Exclusion Criteria: Subjects with diabetes or a history of obesity surgery or with more than modest health problems

Additional Information

Official title How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?
Principal investigator Ajaykumar Rao, MD
Description Study volunteers will be admitted to the Clinical Research Center at Temple University Hospital. After an overnight fast, body composition will be determined non-invasively by bioimpedance analysis (4) and a 4 h euglycemic-hyperinsulinemic clamp (using only FDA-approved regular insulin) as previously described (5) will be performed during which serum samples will be obtained for measurement of glucose, insulin, free fatty acids, ketone bodies and lipids. Oxidative stress ( 6) will be measured by 24 hour urine collections (analyzed for isoprostene content (8-isoPGF 2α) throughout the study period. Respiratory gas exchange rates (7) will be determined at hourly intervals (with a metabolic cart (True One, Parvo Utah) during the clamp studies and once a day on Days 2 through 6. After that, (at about 1 PM on Day 1) the volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h. The main meals (containing ~ 1500 Kcal/meal) will be served at ~ 8AM (breakfast), 1PM (lunch) and ~ 7PM (dinner), the snacks (~ 500 Kcal/each) at ~ 11 AM, 4PM and 11PM. On days 5 and 6, volunteers will receive 3 meals, each will contain ~333 calories. Each morning blood samples will be obtained to measure glucose insulin, free fatty acids and ketone bodies. Daily 24 h urine collections will be obtained each day. In the morning of Days 5 and 7, all procedures described for Day 1 will be repeated. In the afternoon of Day 7, the volunteers will be discharged from the hospital.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Temple University.