Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)
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ClinicalTrials.gov Identifier: NCT00108225 |
Recruitment Status
:
Completed
First Posted
: April 15, 2005
Last Update Posted
: July 1, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Other: LoBag Diet - test phase Other: LoBAG Diet - control phase | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
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 |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | May 2009 |
Arm | Intervention/treatment |
---|---|
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.
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Placebo Comparator: Arm 2
55% carbohydrate, 15% protein, 30% fat
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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
|
- IGF-1, GH, Body Composition [ Time Frame: 5 weeks ]

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Ages Eligible for Study: | 55 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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 exclusion criteria.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108225
United States, Minnesota | |
VA Medical Center, Minneapolis | |
Minneapolis, Minnesota, United States, 55417 |
Principal Investigator: | Mary Gannon, PhD | Minneapolis Veterans Affairs Medical Center |
Publications of Results:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT00108225 History of Changes |
Other Study ID Numbers: |
03448-A |
First Posted: | April 15, 2005 Key Record Dates |
Last Update Posted: | July 1, 2014 |
Last Verified: | June 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 Mecasermin Growth Substances Physiological Effects of Drugs |