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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) - Article


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Clinical Trial: 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 is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

In this study we will test 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 Treatment or Intervention
Diabetes Mellitus, Type 2
 Behavior: LoBag Diet

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

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

Further Study Details: 

Study start: July 2004;  Expected completion: June 2007

Subjects with untreated type 2 diabetes will be studied using a randomized crossover design. The study will begin with an initial two-week observation period. Subjects then will be 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 will be assigned to the other arm of the study. All meals will be 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 will be admitted to the SDTU (Special Diagnostic and Treatment Unit), be provided with the meals appropriate for the test or control arm of the study, and have 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 will be determined.

Eligibility

Ages Eligible for Study:  55 Years   -   75 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108225


Minnesota
      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Patricia Swenson-Green, RN  612-467-2808 
Mary Gannon, Ph.D.,  Principal Investigator
Frank Nuttal, M.D., Ph.D.,  Sub-Investigator

More Information

Study ID Numbers:  03448-A
Record last reviewed:  April 2005
Last Updated:  April 14, 2005
Record first received:  April 14, 2005
ClinicalTrials.gov Identifier:  NCT00108225
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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