"Effect of High Fat and High Glycemic Diets

NCT01494935 | Completed

• 1 other identifier: 10-005948
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will determine whether people with high muscle mitochondrial capacity produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic diet and thus exhibit elevated cellular oxidative damage. The investigators previously found that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin resistance. Somalians are another new immigrant population with rapidly increasing prevalence of diabetes. Both of these groups traditionally consume low caloric density diets, and the investigators hypothesize that when these groups are exposed to high-calorie Western diets, they exhibit increased oxidative stress, oxidative damage, and insulin resistance. The investigators will compare Somalians and NE Americans who are matched for age, BMI, and sex. The investigators will measure ROS production in skeletal muscle following high fat/high glycemic diet vs. healthy diet. The investigators will compare the oxidative damage to proteins, DNA, and lipids in these two populations following 10 days of high fat/high glycemic index diet in comparison with low fat diet. The investigators will determine if elevated levels of oxidative damage in Somali immigrant populations is accompanied by high mitochondrial capacity, higher ROS-emitting potential, and lower insulin sensitivity than NE. The proposed study will be performed utilizing the state-of-the-art proteomic and metabolomic methods many of which were recently developed in our laboratory. The investigators expect the results from this study to provide seminal insights into the underlying mechanism of insulin resistance and type 2 diabetes, in addition to demonstrating mechanisms by which a functional proteome is maintained in vivo.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  The investigators will determine the change from baseline in insulin sensitivity using a hyperinsulinemic euglycemic clamp. Measurments will be performed at baseline and following 10 days of exercise a high fat diet.

  Measured at day 0 (baseline) and day 10 (of high fat meals)

Secondary Outcomes (1)

• ceramides and diacylglycerol

  Measured at day 0 (baseline) and day 10 (of high fat meals)

Study Arms (2)

Normal glycemic diet

EXPERIMENTAL

COntrol diet with fat and glycemic index similar to typical American diet.

Behavioral: Control diet

High-fat, high-glycemic diet

EXPERIMENTAL

High-fat, high-glycemic diet

Behavioral: High Glycemic Diet

Interventions

High Glycemic Diet BEHAVIORAL

NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed

High-fat, high-glycemic diet

Control diet BEHAVIORAL

Normal fat, normal fat diet

Normal glycemic diet

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Somali immigrants age 40-65,
• BMI 23-34 kg/m2,
• sedentary (exercise less than 2 days per week for less than 20 minutes).
• for Northern European descendants same as for Somali immigrants plus need to match a Somali immigrant for age, BMI and habitual activity.

You may not qualify if:

• Triglycerides on screening examination of greater than 300;
• pregnant or lactating women.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55975, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sreekumaran Nair, MD, Ph.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: December 19, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)