Clinical trial NCT00108225: Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)
Official title: 2895 Effect of a High Protein Diet on the 24-hr Profile of Ghrelin, GH and IGF-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Cholesterol
Creatinine Clearance
Diabetes
Glycohemoglobin
High Protein Diet
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: IGF-1, GH, Body Composition
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Mary Gannon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.