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

Insulin Sensitivity Clinical Trial

— BCAAM-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786941
• Other study ID #: Pro00034434
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: October 15, 2015
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Branched-chain Amino Acid Metabolism
• Insulin Resistance
• Insulin Sensitivity

Intervention

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

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	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	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	No