NCT01786941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

February 6, 2013

Last Update Submit

October 15, 2015

Conditions

Branched-chain Amino Acid MetabolismInsulin Sensitivity

Keywords

Branched-chain Amino AcidsInsulin SensitivityExerciseLeucine

Outcome Measures

Primary Outcomes (1)

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

    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

    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 Outcomes (1)

  • Changes in Insulin Sensitivity at Baseline and post-intervention

    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

Study Arms (3)

Lean Group

NO INTERVENTION

Healthy Controls - no intervention

Pre-Diabetes Group

OTHER

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

OTHER

Non-diabetic patients intending to undergo Gastric Bypass surgery

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

Interventions

Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise trainingOTHER
Pre-Diabetes Group
GBP Group - Non-diabetics intending to undergo Gastric Bypass surgeryOTHER
Gastric Bypass Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 26254576DERIVED

MeSH Terms

Conditions

Insulin ResistanceMotor Activity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • William E. Kraus, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

US(1)