The Effect of Exercise on Hepatic Glucose Metabolism

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01783275

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is known that obesity and/or physical inactivity greatly increase a person's risk of developing heart disease and other serious health problems. This is partly because diabetes is associated with inflammation, oxidative stress, and insulin resistance. Diabetes is also associated with high levels of triglycerides in the blood and tissues such as the liver (known as fatty liver or steatosis). This elevation of fat in the liver is known to cause liver insulin resistance and impair the function of the liver and this impairment contributes to the development of diabetes.

Studies have shown that both aerobic exercise and weight loss have beneficial results on insulin resistance. However, the cause of this benefit remains unclear. We know that both aerobic exercise and/or weight loss can improve how muscle responds to insulin. However, it is also known that aerobic exercise and/or weight loss lowers liver fat content, thereby making it possible that the liver's response to insulin is also improved by weight loss and/or exercise training. An improved responsiveness of the liver to insulin could lower blood sugar levels after a meal and it could also lower morning blood sugar levels. However, very little is known about how exercise and/or weight loss improves liver function in people with type 2 diabetes.

Hypothesis 1: Improved hepatic insulin sensitivity, as a result of exercise training will increase the amount of glucose from an oral load that is taken up by the liver in subjects with DM.

Hypothesis 2: Increases in hepatic insulin sensitivity as a result of exercise will cause reductions in EGP during the fasted state, and will improve the suppression of EGP seen in response to hyperinsulinemia.

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes	Behavioral: Aerobic exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Effect of Exercise on Hepatic Glucose Metabolism in Type 2 Diabetes Mellitus

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic Exercise 12 weeks of aerobic exercise	Behavioral: Aerobic exercise 12 weeks of aerobic exercise with weight maintenance
No Intervention: Control 12 weeks with no change in diet or exercise habits (weight maintenance).

Arm

Intervention/Treatment

Experimental: Aerobic Exercise

12 weeks of aerobic exercise

Behavioral: Aerobic exercise

12 weeks of aerobic exercise with weight maintenance

No Intervention: Control

12 weeks with no change in diet or exercise habits (weight maintenance).

Outcome Measures

Primary Outcome Measures

Splanchnic glucose uptake [3 years]
Improved hepatic insulin sensitivity, as a result of lifestyle intervention, will increase the amount of glucose from an oral load that is taken up by the liver in subjects with DM.

Secondary Outcome Measures

Endogenous glucose production [3 years]
Increases in hepatic insulin sensitivity as a result of lifestyle intervention will cause reduced EGP during the fasted state, and in response to hyperinsulinemia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

40-60 yrs of age
sedentary lifestyle
stable weight
BMI 30 - 40kg/m2
Hgb A1c <8.5
Type 2 diabetes

Exclusion Criteria:

Use of insulin
Use of TZDs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator: Jason Winnick, PhD, Vanderbilt University Medical Center
Study Chair: Naji Abumrad, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jason Winnick, Principal Investigator, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01783275

Other Study ID Numbers:

121031
DK093799

First Posted:

Feb 4, 2013

Last Update Posted:

Aug 13, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jason Winnick, Principal Investigator, Vanderbilt University

Obesity

Type 2 diabetes

Liver

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 13, 2018