Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

NCT ID: NCT03155867

Last Updated: 2017-07-02

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

2017-04-05

Study Completion Date

2017-05-18

Brief Summary

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

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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Meal replacement A

Group Type ACTIVE_COMPARATOR

Meal replacement

Intervention Type OTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Meal replacement B

Group Type ACTIVE_COMPARATOR

Meal replacement

Intervention Type OTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Meal replacement C

Group Type ACTIVE_COMPARATOR

Meal replacement

Intervention Type OTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Meal replacement D

Group Type ACTIVE_COMPARATOR

Meal replacement

Intervention Type OTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Meal replacement E

Group Type ACTIVE_COMPARATOR

Meal replacement

Intervention Type OTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Meal replacement F

Group Type ACTIVE_COMPARATOR

Meal replacement

Intervention Type OTHER

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

Interventions

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Meal replacement

The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.

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
* Hematocrit levels within normal limits

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
* Patient 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.
* Patients with Anemia
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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16.11.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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