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

Primary Purpose

Branched-chain Amino Acid Metabolism, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training
GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Branched-chain Amino Acid Metabolism focused on measuring Branched-chain Amino Acids, Insulin Sensitivity, Exercise, Leucine

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Lean Group

Pre-Diabetes Group

Gastric Bypass Group

Arm Description

Healthy Controls - no intervention

Pre-Diabetes Group will undergo a 6-mo Aerobic and Resistance combined exercise training intervention

Non-diabetic patients intending to undergo Gastric Bypass surgery

Outcomes

Primary Outcome Measures

Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention
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 Outcome Measures

Changes in Insulin Sensitivity at Baseline and post-intervention
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

Full Information

First Posted
February 6, 2013
Last Updated
October 15, 2015
Sponsor
Duke University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01786941
Brief Title
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes
Acronym
BCAAM-PD
Official Title
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branched-chain Amino Acid Metabolism, Insulin Sensitivity
Keywords
Branched-chain Amino Acids, Insulin Sensitivity, Exercise, Leucine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean Group
Arm Type
No Intervention
Arm Description
Healthy Controls - no intervention
Arm Title
Pre-Diabetes Group
Arm Type
Other
Arm Description
Pre-Diabetes Group will undergo a 6-mo Aerobic and Resistance combined exercise training intervention
Arm Title
Gastric Bypass Group
Arm Type
Other
Arm Description
Non-diabetic patients intending to undergo Gastric Bypass surgery
Intervention Type
Other
Intervention Name(s)
Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training
Intervention Type
Other
Intervention Name(s)
GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
Primary Outcome Measure Information:
Title
Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention
Description
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
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
Secondary Outcome Measure Information:
Title
Changes in Insulin Sensitivity at Baseline and post-intervention
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E. Kraus, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26254576
Citation
Glynn EL, Piner LW, Huffman KM, Slentz CA, Elliot-Penry L, AbouAssi H, White PJ, Bain JR, Muehlbauer MJ, Ilkayeva OR, Stevens RD, Porter Starr KN, Bales CW, Volpi E, Brosnan MJ, Trimmer JK, Rolph TP, Newgard CB, Kraus WE. Impact of combined resistance and aerobic exercise training on branched-chain amino acid turnover, glycine metabolism and insulin sensitivity in overweight humans. Diabetologia. 2015 Oct;58(10):2324-35. doi: 10.1007/s00125-015-3705-6. Epub 2015 Aug 9.
Results Reference
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Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes

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