Glycemic Response to Oral Nutrition Supplements

November 20, 2015 updated by: Nestlé

Plasma Glucose and Insulin Response to Two Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over study of two oral nutrition supplements in individuals with Type 2 Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229-4801
        • Diabetes & Glandular Disease Clinic, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-75 yrs
  • Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg

Exclusion Criteria:

  • Allergy to milk protein or any other component of the formula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard ONS
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption
Other: ONS
Experimental: Low Carbohydrate ONS
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption
Other: ONS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the blood glucose curve (AUC 0-240)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Sherwyn Schwartz, MD, Diabetes & Glandular Disease Clinic, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 13.10.US.HCN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on ONS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe