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OpenTrials
Completed

NCT Number: NCT01783275

The Effect of Exercise on Hepatic Glucose Metabolism

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

12 weeks of aerobic exercise with weight maintenance

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2013
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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