Study of Changes in Skeletal Muscle After Caloric Restriction

NCT00993460 | Active Not Recruiting

• 1 other identifier: IRB #091145
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Research has shown that fat stored within muscles affects the muscle's sensitivity to insulin and ability to handle blood glucose. The purpose of this study is to examine the effects of weight loss surgery-induced caloric restriction on the accumulation and types of fats within skeletal muscle, as well as the effects of such caloric restriction on insulin sensitivity and inflammatory responses in skeletal muscle. The investigator proposes that caloric restriction will result in decreases in diacylglycerols enriched with saturated fat and increases in diacylglycerols enriched with monounsaturated fats.

Conditions

Obesity

Keywords

Obesity; Insulin sensitivity; Inflammation

Outcome Measures

Primary Outcomes (1)

• UPLC-ESI MS/MS profiling of lipd extracts from muscle biopsies to evaluate effects of gastric bypass induced-caloric restriction on diacylglycerol molecular species accumulation.

  1 year

Secondary Outcomes (2)

• To evaluate the effects of gastric bypass induced-caloric restriction on skeletal muscle insulin action via a hyperinsulinemic-euglycemic clamp and profiling markers of insulin signaling.

  1 year

• To evaluate the effects of gastric bypass induced-caloric restriction on lipid-mediated inflammatory responses by profiling cytokines and free fatty acids in blood and inflammation markers in skeletal muscle biopsies.

  1 year

Study Arms (2)

Normal body weight

Female subjects, ages 21-65 yrs, with BMI of 21-27 kg/m2 with normal glucose tolerance.

Roux-en-Y gastric bypass

Female subjects ages 21-65 with insulin resistance and scheduled for Roux-en-Y gastric bypass at Vanderbilt University Medical Center will be studied before and 4-6 weeks after surgery.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects approved for Roux-en-Y gastric bypass surgery at Vanderbilt University Medical Center.

You may qualify if:

• For Normal Weight Subjects:
• Age 21-65 years
• BMI of 21 to 27 kg/m2
• Normal glucose tolerance as determined by OGTT on day of screening
• No family history of diabetes
• For Morbidly Obese Subjects:
• Age 21-65 years
• BMI of 30 to 65 kg/m2
• Scheduled for Roux-en-Y gastric bypass at Vanderbilt Medical Center
• Insulin resistant as determined by OGTT on day of screening

You may not qualify if:

• Clinically significant heart disease
• Clinically significant hepatic or renal disease
• Pregnancy
• Breastfeeding
• Any abnormality that would preclude safe completion of study
• Use of statins
• Use of thiazide or furosemide diuretics, beta blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless subject has been on stable dose of such medications for the past 3 months before entering the study

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, muscle tissue

MeSH Terms

Conditions

Obesity; Insulin Resistance; Inflammation

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; Pathologic Processes

Study Officials

• Charles R Flynn, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Naji Abumrad, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 12, 2009
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)