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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Assessment of Glycemic Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822367
• Other study ID #: 06-10010
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: January 13, 2009
• Start date: May 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2009
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No