"Effect of High Fat and High Glycemic Diets
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: High Glycemic Diet Behavioral: Control diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effect of High Fat and High Glycemic Diets on Muscle Protein Synthesis in Somali Immigrants and Americans of Northern European Descent |
- Insulin Sensitivity [ Time Frame: Measured at day 0 (baseline) and day 10 (of high fat meals) ] [ Designated as safety issue: No ]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.
- ceramides and diacylglycerol [ Time Frame: Measured at day 0 (baseline) and day 10 (of high fat meals) ] [ Designated as safety issue: No ]The investigators will determine the change from baseline in skeletal insulin ceramide and diacylglycerol concentrations. Measurments will be performed at baseline and following 10 days of exercise a high fat diet.
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Normal glycemic diet
COntrol diet with fat and glycemic index similar to typical American diet.
|
Behavioral: Control diet
Normal fat, normal fat diet
|
|
Experimental: High-fat, high-glycemic diet
High-fat, high-glycemic diet
|
Behavioral: High Glycemic Diet
NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed
|
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Somali immigrants age 40-65,
- BMI 23-34 kg/m2,
- sedentary (exercise less than 2 days per week for less than 20 minutes).
Inclusion criteria:
- for Northern European descendants same as for Somali immigrants plus need to match a Somali immigrant for age, BMI and habitual activity.
Exclusion Criteria:
- Triglycerides on screening examination of greater than 300;
- pregnant or lactating women.
Contacts and Locations| Contact: Sreekumaran Nair, MD, PhD. | 507-255-2949 | nair@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55975 | |
| Contact: Sreekumaran Nair, MD, Ph.D 507-255-2949 nair@mayo.edu | |
| Principal Investigator: Sreekumaran Nair, MD, Ph.D | |
| Principal Investigator: | Sreekumaran Nair, MD, Ph.D | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | K. Sreekumaran Nair, Md, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01494935 History of Changes |
| Other Study ID Numbers: | 10-005948 |
| Study First Received: | November 18, 2011 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013