Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes (BCAAM-PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01786941
First received: February 6, 2013
Last updated: March 4, 2014
Last verified: March 2014

February 6, 2013
March 4, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  1. Lean Healthy Controls - Baseline only
  2. Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention
  3. Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery
Same as current
Complete list of historical versions of study NCT01786941 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  1. Lean Healthy Controls - Baseline only
  2. Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention
  3. Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery
Same as current
Not Provided
Not Provided
 
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Branched-chain Amino Acid Metabolism
  • Insulin Sensitivity
  • Other: Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training
  • Other: GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
  • No Intervention: Lean Group
    Healthy Controls - no intervention
  • Pre-Diabetes Group
    Pre-Diabetes Group will undergo a 6-mo Aerobic and Resistance combined exercise training intervention
    Intervention: Other: Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training
  • Gastric Bypass Group
    Non-diabetic patients intending to undergo Gastric Bypass surgery
    Intervention: Other: GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
Not Provided
December 2014   (final data collection date for primary outcome measure)

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)
Both
30 Years to 65 Years
Yes
Contact: Lucy W Piner, MS 919-660-6781 lucy.piner@duke.edu
United States
 
NCT01786941
Pro00034434
Not Provided
Duke University
Duke University
Pfizer
Principal Investigator: William E. Kraus, MD Duke University
Duke University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP