How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | July 2016 |
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.
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.
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.
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.
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
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