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The Effect of Exercise on Hepatic Glucose Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Winnick, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01783275
First received: July 19, 2012
Last updated: February 20, 2017
Last verified: February 2017
  Purpose

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 either exercise training or weight loss, will increase the amount of glucose from an oral load that is taken up by the liver in subjects with DM. We also hypothesize that the amount of glucose taken up by the liver will be increased even further in response to exercise training plus weight loss compared to either treatment alone.

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


Condition Intervention
Obesity Type 2 Diabetes Behavioral: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: The Effect of Exercise on Hepatic Glucose Metabolism in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Jason Winnick, Vanderbilt University:

Primary Outcome Measures:
  • Splanchnic glucose uptake [ Time Frame: 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 [ Time Frame: 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. This reduction will be accounted for by reductions in glycogenolysis


Enrollment: 20
Study Start Date: February 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783275

Locations
United States, Tennessee
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
  More Information

Responsible Party: Jason Winnick, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01783275     History of Changes
Other Study ID Numbers: 121031
DK093799 ( Other Identifier: NIDDK )
Study First Received: July 19, 2012
Last Updated: February 20, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason Winnick, Vanderbilt University:
Obesity
Type 2 diabetes
Liver

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 23, 2017