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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 180
Study Start Date: June 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training
Gastric Bypass Group
Non-diabetic patients intending to undergo Gastric Bypass surgery
Other: GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  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: NCT01786941

Contacts
Contact: Lucy W Piner, MS 919-660-6781 lucy.piner@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Lucy W Piner, MS    919-660-6781    lucy.piner@duke.edu   
Principal Investigator: William E Kraus, MD         
Principal Investigator: Christopher Newgard, MD         
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: William E. Kraus, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01786941     History of Changes
Other Study ID Numbers: Pro00034434
Study First Received: February 6, 2013
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Branched-chain Amino Acids
Insulin Sensitivity
Exercise
Leucine

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Insulin Resistance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on July 22, 2014