Text Size

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: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

In this study we will test 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.


Condition Intervention
Diabetes Mellitus, Type 2
 Other: LoBag Diet - test phase
Other: LoBAG Diet - control phase

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 2895 Effect of a High Protein Diet on the 24-hr Profile of Ghrelin, GH and IGF-1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • IGF-1, GH, Body Composition [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2004
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
30% carbohydrate, 30% protein, 40% fat
 Other: LoBag Diet - test phase
A Low Biologically Available Glucoe (LOBAG30), weight maintaining diet consisting of 30% carbohydrate, 30% protein, 40% fat will be provided to subjects for 5 weeks.
Placebo Comparator: Arm 2
55% carbohydrate, 15% protein, 30% fat
 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

Detailed Description:

Subjects with untreated type 2 diabetes will be studied using a randomized crossover design. The study will begin with an initial two-week observation period. Subjects then will be 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 will be assigned to the other arm of the study. All meals will be 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 will be admitted to the SDTU (Special Diagnostic and Treatment Unit), be provided with the meals appropriate for the test or control arm of the study, and have 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 will be determined.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108225

Locations
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Mary Gannon, PhD Minneapolis Veterans Affairs Medical Center
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108225     History of Changes
Other Study ID Numbers: 03448-A
Study First Received: April 14, 2005
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cholesterol
Creatinine Clearance
Diabetes
Glycohemoglobin
High Protein Diet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013