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

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00822367
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 13, 2009
January 13, 2009
May 2006
August 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes
Assessment of Glycemic Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes Mellitus

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Diabetes Mellitus Type 2
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
Experimental: Nutritional suplements
Intervention: Dietary Supplement: Glucerna; Ensure; SlimFast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
September 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00822367
06-10010
No
Asha Jain, M.A., R.D., C.D.E., Walter Reed Army Medical Center
Walter Reed Army Medical Center
Not Provided
Study Director: Robert A Vigersky, COL. MC. MD. Walter Reed Army Medical Center
Walter Reed Army Medical Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP