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
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014