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

Insulin Resistance Clinical Trial

Official title:

Lipid and Carbohydrate Metabolism: Effects of Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196051
• Other study ID #: 0710003207
• Secondary ID: R56AG023686
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 29, 2020

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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) will undergo 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis will be determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies will be performed in 3 sets: Study Part 1: Resting, Study Part 2: After 1 bout of exercise and Study part 3: After 6 weeks of exercise training. Since intra-abdominal obesity has been postulated to be at the core of the metabolic derangements and directly responsible for the atherogenic dyslipidemia associated with the metabolic syndrome, the investigators will also measure intra-abdominal fat content by magnetic resonance imaging (MRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• Exercise Training
Six weeks of exercise

Locations

Country	Name	City	State
United States	YCCI/YNNH Hospital Research Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Flannery C, Dufour S, Rabøl R, Shulman GI, Petersen KF. Skeletal muscle insulin resistance promotes increased hepatic de novo lipogenesis, hyperlipidemia, and hepatic steatosis in the elderly. Diabetes. 2012 Nov;61(11):2711-7. doi: 10.2337/db12-0206. Epub — View Citation

Rabøl R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in de novo lipogenesis	At the baseline assessment, de novo lipogenesis will be assessed by giving a high carbohydrate meal and heavy water to drink. Muscle glycogen and lipid contents pre- and post meal will be measured using 1H/13C MRS and de novo lipogenesis will be assessed from the heavy water incorporation into blood lipid in samples collected overnight.	Baseline
Primary	change in de novo lipogenesis	At the 6 weeks assessment, de novo lipogenesis will be assessed by giving a high carbohydrate meal and heavy water to drink. Muscle glycogen and lipid contents pre- and post meal will be measured using 1H/13C MRS and de novo lipogenesis will be assessed from the heavy water incorporation into blood lipid in samples collected overnight.	6 weeks