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The Effect of Exercise on Hepatic Glucose Metabolism

Primary Purpose

Obesity, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Type 2 diabetes, Liver

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic Exercise

Control

Arm Description

12 weeks of aerobic exercise

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

Outcomes

Primary Outcome Measures

Splanchnic glucose uptake
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
Increases in hepatic insulin sensitivity as a result of lifestyle intervention will cause reduced EGP during the fasted state, and in response to hyperinsulinemia.

Full Information

First Posted
July 19, 2012
Last Updated
August 9, 2018
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01783275
Brief Title
The Effect of Exercise on Hepatic Glucose Metabolism
Official Title
The Effect of Exercise on Hepatic Glucose Metabolism in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Obesity, Type 2 diabetes, Liver

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
12 weeks of aerobic exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
12 weeks with no change in diet or exercise habits (weight maintenance).
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
12 weeks of aerobic exercise with weight maintenance
Primary Outcome Measure Information:
Title
Splanchnic glucose uptake
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Endogenous glucose production
Description
Increases in hepatic insulin sensitivity as a result of lifestyle intervention will cause reduced EGP during the fasted state, and in response to hyperinsulinemia.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Winnick, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naji Abumrad, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Exercise on Hepatic Glucose Metabolism

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