Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.

Not Applicable

Completed

• Conditions: Insulin Resistance

• Registration Number: NCT02196051
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.

Detailed Description

In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.

The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2012-01-30
• Study Completion: 2012-01-30
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Body Mass Index < 29 kg/m2
• No regular exercise routine
• Non-smokers
• Absence of systemic and organ disease.

Exclusion Criteria

• Hematocrit < 35 vol%
• History of claustrophobia
• Ferromagnetic implants
• Regular exercise regimen
• Not weight stable
• Any significant hematological, neurological, musculoskeletal or endocrine disease (including diabetes mellitus)
• Any significant cardiovascular condition, including confirmed CAD and prior cardiovascular events
• Taking coumadin as anticoagulant therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in de novo lipogenesis	Baseline	At the baseline assessment, de novo lipogenesis was assessed after a high carbohydrate meal and a drink of heavy water. Muscle glycogen and lipid contents were measured pre- and post meal using 1H/13C MRS and de novo lipogenesis was assessed from the heavy water incorporation into blood lipid in samples collected overnight.

Trial Locations

Locations (1)

YCCI/YNNH Hospital Research Unit; 🇺🇸 New Haven, Connecticut, United States