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

NCT01786941

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Branched-chain Amino Acid Metabolism, Insulin Sensitivity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Branched-chain Amino Acid Metabolism, Insulin SensitivityRegulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes
NCT01786941
  1. Durham, North Carolina
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes
Official Title  ICMJE Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Branched-chain Amino Acid Metabolism
  • Insulin Sensitivity
Intervention  ICMJE
  • Other: Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training
  • Other: GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2014)
132
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
60
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01786941
Other Study ID Numbers  ICMJE Pro00034434
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:William E. Kraus, MDDuke University
PRS Account Duke University
Verification Date October 2015

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