Glycemic Response to Oral Nutrition Supplements

NCT ID: NCT02612675

Last Updated: 2015-11-24

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard ONS

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption

Group Type ACTIVE_COMPARATOR

ONS

Intervention Type OTHER

Low Carbohydrate ONS

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption

Group Type EXPERIMENTAL

ONS

Intervention Type OTHER

Interventions

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ONS

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherwyn Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes & Glandular Disease Clinic, PA

Locations

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Diabetes & Glandular Disease Clinic, PA

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Huhmann MB, Smith KN, Schwartz SL, Haller SK, Irvin S, Cohen SS. Plasma glucose and insulin response to two oral nutrition supplements in adults with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2016 Aug 31;4(1):e000240. doi: 10.1136/bmjdrc-2016-000240. eCollection 2016.

Reference Type DERIVED
PMID: 27648290 (View on PubMed)

Other Identifiers

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13.10.US.HCN

Identifier Type: -

Identifier Source: org_study_id