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Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)
This study has been completed.
Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00108225
First received: April 14, 2005
Last updated: June 30, 2014
Last verified: June 2014
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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 Intervention Model: Crossover Assignment Masking: None (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 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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:
| 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 |
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 21, 2017