Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Mellitus Type 2	Dietary Supplement: Glucerna; Ensure; SlimFast

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Assessment of Glycemic Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Type 2 Dietary Supplements Tremor

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

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 [ Time Frame: BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	May 2006
Study Completion Date:	September 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nutritional suplements	Dietary Supplement: 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. Other Name: Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast Shake

Arms

Assigned Interventions

Experimental: Nutritional suplements

Dietary Supplement: 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.

Other Name: Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast Shake

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822367

Sponsors and Collaborators

Walter Reed Army Medical Center

Investigators

Study Director:

Robert A Vigersky, COL. MC. MD.

Walter Reed Army Medical Center

More Information

No publications provided

Responsible Party:	Asha Jain, M.A., R.D., C.D.E., Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00822367 History of Changes
Other Study ID Numbers:	06-10010
Study First Received:	January 13, 2009
Last Updated:	January 13, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013