How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?

NCT02505958 | Unknown

• 2 other identifiers: 22331R01DK090588
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

insulin resistance, obesity, caloric intake

Outcome Measures

Primary Outcomes (5)

• Changes in insulin resistance

  Insulin resistance will be determined by measuring changes in insulin-stimulated total body glucose uptake during euglycemic hyperinsulinemic clamping

  baseline, day 4 and day 7

• Changes in oxidative stress

  24 hour urine collections analyzed for isoprostane content

  baseline, day1, day 2, day 3, day 4, day 5, day 6, day 7

• Changes in energy expenditure

  Changes in energy expenditure will be assessed with a metabolic cart (indirect calorimetry)

  baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

• Changes in weight

  Subjects will be weighed daily

  baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

• Changes in body composition

  Body composition will be determined by bioelectric impedance analysis

  baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

Secondary Outcomes (5)

• Changes in blood glucose levels

  baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

• Changes in blood levels of insulin

  Baseline, day1 day2, day 3, day 4, day 5, day 6, day 7

• Changes in blood levels of free fatty acids

  Baseline, day1 , day 2, day 3, day 4, day 5, day 6, day 7

• Changes in blood ketone levels

  baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

• Changes in glucagon levels

  baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7

Study Arms (2)

high caloric intake

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.

Other: high caloric intake

reduced caloric intake

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.

Other: reduced caloric intake

Interventions

high caloric intake OTHER

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.

high caloric intake

reduced caloric intake OTHER

On days 5 and 6, volunteers will received 3 meals (\~333 calories each) totaling \~ 1,000 calories/24 hours.

reduced caloric intake

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Ajaykumar Rao, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2014
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

US (1)