Diabetes-Specific Nutritional Formulas Versus Oatmeal

NCT ID: NCT02691481

Last Updated: 2016-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Oatmeal breakfast

consuming 200 kcal of plain cooked oatmeal for breakfast

Group Type ACTIVE_COMPARATOR

Oatmeal breakfast

Intervention Type DIETARY_SUPPLEMENT

Glucerna formula

Intervention Type DIETARY_SUPPLEMENT

Ultra Glucose Control formula

Intervention Type DIETARY_SUPPLEMENT

Glucerna formula

consuming 200 kcal of Glucerna shake for breakfast

Group Type ACTIVE_COMPARATOR

Oatmeal breakfast

Intervention Type DIETARY_SUPPLEMENT

Glucerna formula

Intervention Type DIETARY_SUPPLEMENT

Ultra Glucose Control formula

Intervention Type DIETARY_SUPPLEMENT

Ultra Glucose Control formula

consuming 200 kcal of Ultra Glucose Control shake for breakfast

Group Type ACTIVE_COMPARATOR

Oatmeal breakfast

Intervention Type DIETARY_SUPPLEMENT

Glucerna formula

Intervention Type DIETARY_SUPPLEMENT

Ultra Glucose Control formula

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oatmeal breakfast

Intervention Type DIETARY_SUPPLEMENT

Glucerna formula

Intervention Type DIETARY_SUPPLEMENT

Ultra Glucose Control formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes treated with oral diabetes medications

Exclusion Criteria

* Type 1 diabetes
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joslin Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2014-01

Identifier Type: -

Identifier Source: org_study_id

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