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 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.

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

Further study details as provided by VA Office of Research and Development:

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 Glucose (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 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.

Eligibility


Ages Eligible for Study:	55 Years to 75 Years (Adult, Senior)
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

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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

VA Office of Research and Development

Investigators


Principal Investigator:	Mary Gannon, PhD	Minneapolis Veterans Affairs Medical Center

More Information

Publications:

Gannon MC, Nuttall FQ. Effect of a high-protein diet on ghrelin, growth hormone, and insulin-like growth factor-I and binding proteins 1 and 3 in subjects with type 2 diabetes mellitus. Metabolism. 2011 Sep;60(9):1300-11. doi: 10.1016/j.metabol.2011.01.016. Epub 2011 Mar 15.

Nuttall FQ, Gannon MC. Effect of a LoBAG30 diet on protein metabolism in men with type 2 diabetes. A Randomized Controlled Trial. Nutr Metab (Lond). 2012 May 20;9(1):43. doi: 10.1186/1743-7075-9-43.


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00108225 History of Changes
Other Study ID Numbers:	03448-A
Study First Received:	April 14, 2005
Last Updated:	June 30, 2014
Health Authority:	United States: Federal Government

Keywords provided by VA Office of Research and Development:


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 September 30, 2016