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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108225
• Other study ID #: 03448-A
• Status: Completed
• Phase: N/A
• First received: April 14, 2005
• Last updated: June 30, 2014
• Start date: July 2004
• Est. completion date: May 2009

Study information

• Verified date: June 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.2011.01.01 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF-1, GH, Body Composition		5 weeks	No