Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

NCT ID: NCT02856516

Last Updated: 2016-10-11

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

Brief Summary

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This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.

Detailed Description

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Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.

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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Boost Glucose Control (A)

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Group Type EXPERIMENTAL

Boost Glucose Control (A)

Intervention Type OTHER

Oral nutrition supplement

Boost Glucose Control (B)

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Group Type EXPERIMENTAL

Boost Glucose Control (B)

Intervention Type OTHER

Oral nutrition supplement

Boost Original

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.

Group Type ACTIVE_COMPARATOR

Boost Original

Intervention Type OTHER

Oral nutrition supplement

Interventions

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Boost Glucose Control (A)

Oral nutrition supplement

Intervention Type OTHER

Boost Glucose Control (B)

Oral nutrition supplement

Intervention Type OTHER

Boost Original

Oral nutrition supplement

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 alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patients who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.
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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Joel Neutel, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Research Center

Locations

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Orange County Research Center

Tustin, California, United States

Site Status

Countries

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United States

Other Identifiers

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15.11.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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