Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Dietary Supplement: Glucerna; Ensure; SlimFast

• Registration Number: NCT00822367
• Lead Sponsor: Walter Reed Army Medical Center

Brief Summary

The purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours later after a meal. Therefore, the best product would be the one that produces a smallest rise in blood sugar.

Detailed Description

The purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the post-prandial blood glucose (BG) responses in response to 3 different nutritional supplements each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and relate these responses to one of the two well-recognized indices of insulin sensitivity - HOMA-R and QUICKI.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Status Verified: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Last Update Submitted: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Ages 18-75 years
• Type-2 diabetes mellitus for over 3 months
• A1c of 7.0 - 10.0% within the past 3 months
• Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
• Able to give informed consent
• Expected to be in the DC metropolitan for the duration of the study
• Fasting blood glucose between 70 and 250 mg/dl

Exclusion Criteria

• Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
• A1c under 7.0% or over 10.0%
• Fasting blood glucose < 70 or > 250 mg/d
• Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
• Clinical history of documented gastroperesis.
• Patients on hemodialysis or peritoneal dialysis
• Pregnancy
• Inability to read and/or speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional suplements	Glucerna; Ensure; SlimFast	-

Primary Outcome Measures

Name	Time	Method
To determine the nutritional supplements glycemic response in patients with DM, defined as the maximum glucose excursion, area under the curve, and 2 and 3 hour BG levels fol	BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement.