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Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108225
First received: April 14, 2005
Last updated: June 30, 2014
Last verified: June 2014

April 14, 2005
June 30, 2014
July 2004
December 2008   (final data collection date for primary outcome measure)
IGF-1, GH, Body Composition [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00108225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)
2895 Effect of a High Protein Diet on the 24-hr Profile of Ghrelin, GH and IGF-1

In this study we tested the hypothesis that an increase in protein content of the diet will result in an increase in the 24-hour integrated circulating growth hormone (GH) and insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in people with untreated type 2 diabetes.

Subjects with untreated type 2 diabetes were studied using a randomized crossover design. The study began with an initial two-week observation period. Subjects then were randomly assigned to one arm of the study for 5 weeks. The carbohydrate:protein:fat ratio for the control diet is 55:15:30 whereas for the test diet it is 40:30:30. Following a five-week washout period, subjects were assigned to the other arm of the study. All meals were provided by the SDTU. A six-day rotating meal plan has been devised. At the beginning and end of the 5-week diet period, the subject was admitted to the SDTU (Special Diagnostic and Treatment Unit), was provided with the meals appropriate for the test or control arm of the study, and had blood drawn at various times during a 24-hour period. In addition to measurement of GH and IGF-1, IGF-binding proteins 1 and 3, ghrelin, and body composition were determined.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Other: LoBag Diet - test phase
    A Low Biologically Available Glucose (LOBAG30), weight maintaining diet consisting of 30% carbohydrate, 30% protein, 40% fat will be provided to subjects for 5 weeks.
  • Other: LoBAG Diet - control phase
    A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks
  • Active Comparator: Arm 1
    30% carbohydrate, 30% protein, 40% fat
    Intervention: Other: LoBag Diet - test phase
  • Placebo Comparator: Arm 2
    55% carbohydrate, 15% protein, 30% fat
    Intervention: Other: LoBAG Diet - control phase

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • People ages 55 - 75 years old with type 2 diabetes, not receiving oral hypoglycemic agents or insulin.
  • Fasting plasma glucose < 250 mg/dl (<14 mM) (tGHb < 14%).

Exclusion Criteria:

  • Subjects will be screened for hematological abnormalities, liver disease, kidney disease, macroalbuminuria (>300 mg/24 hours), untreated thyroid disease, congestive heart failure, angina, life-threatening malignancies, proliferative retinopathy, diabetic neuropathy, peripheral vascular disease, serious psychological disorders, a body mass index > 35, and a fasting triglyceride of > 400 mg/dl.
  • Presence of any of the above will be considered exclusion criteria.
Both
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108225
03448-A
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Mary Gannon, PhD Minneapolis Veterans Affairs Medical Center
Department of Veterans Affairs
June 2014

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