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

NCT00822367 | Completed

• 1 other identifier: 06-10010
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Nutritional suplements

EXPERIMENTAL

Dietary Supplement: Glucerna; Ensure; SlimFast

Interventions

Glucerna; Ensure; SlimFast 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.

Also known as: Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast Shake

Nutritional suplements

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucerna

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert A Vigersky, COL. MC. MD.

  Walter Reed Army Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 14, 2009

Record last verified: 2009-01