Effect of a High Protein Diet on the 24-Hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-Like Growth Factor-1) - Full Text View

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

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin-like growth factor I Mecasermin rinfabate Cholest-5-en-3-ol (3beta)- Somatotropin Somatropin Creatinine Ghrelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

Official Title:	2895 Effect of a High Protein Diet on the 24-hr Profile of Ghrelin, GH and IGF-1

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 ]

Estimated Enrollment:	9
Study Start Date:	July 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Placebo Comparator 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

Responsible Party:	Department of Veterans Affairs ( Gannon, Mary - Principal Investigator )
Study ID Numbers:	03448-A
First Received:	April 14, 2005
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00108225
Health Authority:	United States: Federal Government