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

Tracking Information

First Received Date ^ICMJE

January 13, 2009

Last Updated Date

January 13, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus Type 2

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Nutritional suplements

Intervention: Dietary Supplement: Glucerna; Ensure; SlimFast

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00822367

Other Study ID Numbers ^ICMJE

06-10010

Has Data Monitoring Committee

Responsible Party

Asha Jain, M.A., R.D., C.D.E., Walter Reed Army Medical Center

Study Sponsor ^ICMJE

Walter Reed Army Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Robert A Vigersky, COL. MC. MD.

Walter Reed Army Medical Center

Information Provided By

Walter Reed Army Medical Center

Verification Date

January 2009

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

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