Diabetes Mellitus, Type 2
Conditions
Keywords
Cholesterol, Creatinine Clearance, Diabetes, Glycohemoglobin, High Protein Diet
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.
Interventions
OTHERLoBag 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.
OTHERLoBAG Diet - control phase
A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IGF-1, GH, Body Composition | 5 weeks |
Countries
United States
Outcome results
None listed