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OpenTrials
Completed

NCT Number: NCT02043405

Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity

The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)
  • Ages ranging from 30-60 years old;
  • Individuals with:
  • impaired fasting glucose (IFG), (between 100-125mg/dl, with post-prandial glucose (<140 mg/dl 2 hrs after 75g OGTT)
  • impaired glucose tolerance (IGT), (normal fasting glucose <100mg/dl, with post-prandial glucose (>140 mg/dl 2 hrs after 75g OGTT)
  • a combination of the two (IFG/IGT) (both impaired fasting glucose (100-125mg/dl), and impaired glucose tolerance (>140 mg/dl 2 hrs after 75g OGTT), will be verified using oral glucose tolerance testing at initial screening, and
  • Sedentary (<2 hours/week of planned physical activity).

To increase generalizability, and because each subject serves as their own control, women will be enrolled regardless of menopausal status, use of hormone replacement therapy and oral contraceptives.

Exclusion criteria

  • Regular exercise more than 2 hours/week,
  • medications that could affect glucose,
  • lipid metabolism,
  • thyroid disease,
  • history of lung disease,
  • pregnancy,
  • active cigarette smoking or exposure to second hand smoke, and
  • Severe plasma lipid disorders.

Treatment and study plan

Weight loss and exercise training intervention

Behavioral

Combined weight loss and exercise training intervention

Weight loss Only Intervention

Behavioral

Weight loss Only Intervention

Primary outcomes

  1. Change in insulin sensitivity

    Time frame: baseline and 3 months

    Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention

Secondary outcomes

  1. Change in membrane localized diacylglycerol species

    Time frame: baseline and 3 months

    Change in concentration of membrane and cytosolic diacylglycerol species before and after the intervention. Diacylglycerol is a lipid known to be related to insulin resistance.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Apr 25, 2022

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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