Diabetes-Specific Nutritional Formulas Versus Oatmeal

February 22, 2016 updated by: Joslin Diabetes Center

Effect of Diabetes-specific Formulas on Glucose Metabolism and GLP-1 Secretion in Patients With Type 2 Diabetes

Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma glucose is not yet known.

The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty acids (FFA) and serum triglycerides (TG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 2 diabetes treated with oral diabetes medications

Exclusion Criteria:

  • Type 1 diabetes

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oatmeal breakfast
consuming 200 kcal of plain cooked oatmeal for breakfast
Dietary supplement: Oatmeal breakfast
Dietary supplement: Glucerna formula
Dietary supplement: Ultra Glucose Control formula
Active Comparator: Glucerna formula
consuming 200 kcal of Glucerna shake for breakfast
Dietary supplement: Oatmeal breakfast
Dietary supplement: Glucerna formula
Dietary supplement: Ultra Glucose Control formula
Active Comparator: Ultra Glucose Control formula
consuming 200 kcal of Ultra Glucose Control shake for breakfast
Dietary supplement: Oatmeal breakfast
Dietary supplement: Glucerna formula
Dietary supplement: Ultra Glucose Control formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose area under the curve 0-240 minutes
Time Frame: 240 minutes
240 minutes

Collaborators and Investigators

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

Sponsor

Joslin Diabetes Center

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

May 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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