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

NCT ID: NCT00822367

Last Updated: 2009-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-09-30

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Nutritional suplements

Group Type: EXPERIMENTAL

Glucerna; Ensure; SlimFast

Intervention Type: DIETARY_SUPPLEMENT

Each participant will consume all three nutritional supplements randomly assigned by computer program to drink one of the three products in one week intervals. Each product will contain 50 grams of carbohydrate but differs in volume, fat, protein, and fiber composition. BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. The participants will have 8 finger stick blood sugar measurements over about 3 hours on each of the 3 testing days.

Interventions

Glucerna; Ensure; SlimFast

Each participant will consume all three nutritional supplements randomly assigned by computer program to drink one of the three products in one week intervals. Each product will contain 50 grams of carbohydrate but differs in volume, fat, protein, and fiber composition. BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. The participants will have 8 finger stick blood sugar measurements over about 3 hours on each of the 3 testing days.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast Shake

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Walter Reed Army Medical Center

Principal Investigators

Robert A Vigersky, COL. MC. MD.

Role: STUDY_DIRECTOR

Walter Reed Army Medical Center

Other Identifiers

06-10010

Identifier Type: -

Identifier Source: org_study_id