Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)

NCT00108225 | Completed

• 1 other identifier: 03448-A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Cholesterol; Creatinine Clearance; Diabetes; Glycohemoglobin; High Protein Diet

Outcome Measures

Primary Outcomes (1)

• IGF-1, GH, Body Composition

  5 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

30% carbohydrate, 30% protein, 40% fat

Other: LoBag Diet - test phase

Arm 2

PLACEBO COMPARATOR

55% carbohydrate, 15% protein, 30% fat

Other: LoBAG Diet - control phase

Interventions

LoBag Diet - test phase OTHER

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.

Arm 1

LoBAG Diet - control phase OTHER

A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks

Arm 2

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (2)

• 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.

  PMID: 21406307 RESULT

• 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.

  PMID: 22607113 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mary Gannon, PhD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: July 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: May 1, 2009
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

US (1)