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NCT Number: NCT01786941

Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes

Elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. This study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels of the branched-chain amino acids may contribute to the development of insulin resistance and ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as insulin sensitivity improves. This information will be used to further our understanding of the development of insulin resistance and type 2 diabetes in at-risk populations and potentially improve clinical treatment of such conditions.

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Key information

Conditions

Branched-chain Amino Acid Metabolism Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age:
  • Lean and Overweight Pre-diabetic (PD) groups: 40-65 years
  • Obese Gastric Bypass (GBP) patients: 30-65 years
  • Body Mass Index (BMI) within desired range for group:
  • Lean group: 18.0 - 24.9
  • Overweight PD group: 25.0 - 35.4
  • GBP group: 35.0 - 50.0
  • Fasting Plasma Glucose level within desired range for group:
  • Lean: < 99 mg/dL
  • PD: > 105 - < 126 mg/dL
  • GBP: > 99
  • Oral Glucose Tolerance Test, 2-hour Plasma Glucose results within desired range:
  • Lean: < 139 mg/dL
  • PD: 140-199 mg/dL
  • Low density (LDL) cholesterol: < 190 mg/dL
  • Triglycerides: < 600 mg/dL
  • Resting blood pressure: <160/90 mmHg
  • Inactive: Exercise < two days/week (GBP and PD only);
  • Peak oxygen use: > 14.0 - < 40.0 ml/kg/min (PD only)
  • Medications: Stable use of all medications for > three months
  • Body Weight < 495 lbs

Exclusion criteria

  • Smoker: Tobacco use within the last 12 months
  • Dieting or intending to diet (excluding intention for gastric bypass procedure in GBP group)- Not weight stable for > six months or weight loss exceeding five pounds in last six months
  • Use of potential confounding medications, e.g. Niacin containing drugs
  • History of diabetes, heart disease or taking medication for those conditions
  • History of hypertension (high blood pressure) not controlled with medication
  • Pregnant or intending to become pregnant
  • Unwillingness to participate in study visits, submit to skeletal muscle biopsies and all other study testing or continuously participate in the exercise training intervention program for six months if in overweight PD group
  • Orthopedic limitations, musculoskeletal disease and/or injury
  • Allergic to xylocaine
  • Inability to give blood continuously through an intravenous catheter
  • Unwillingness to exercise at least three times per week at the Duke Center for Living during staff supervised times (PD only)
  • Exercise compliance less than 85% in any 6 week period (missing > 3 exercise sessions in a 6 week period)

Treatment and study plan

Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training

Other

GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery

Other

Primary outcomes

  1. Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention

    Time frame: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery

    • Lean Healthy Controls - Baseline only
    • Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention
    • Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery

Secondary outcomes

  1. Changes in Insulin Sensitivity at Baseline and post-intervention

    Time frame: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery

    • Lean Healthy Controls - Baseline only
    • Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention
    • Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Pfizer

Registry information

Official study title

Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery

Acronym: BCAAM-PD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 8, 2013
Registry last updated
Oct 19, 2015

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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