Glycemic Response in Persons With Type 2 Diabetes Mellitus

NCT ID: NCT04168541

Last Updated: 2025-05-15

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-04-18

Brief Summary

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This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Study staff will not be blinded to product assignment. Study participants will be blinded to product assignment. Product will be provided in unlabeled plastic cups.

Study Groups

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Oral Nutrition Supplement A

Product containing calories from carbohydrate, protein, and fat

Group Type ACTIVE_COMPARATOR

Oral Nutrition Supplement

Intervention Type OTHER

Product intake of oral nutrition supplement provided

Oral Nutrition Supplement B

Product containing calories from carbohydrate, protein, and fat

Group Type ACTIVE_COMPARATOR

Oral Nutrition Supplement

Intervention Type OTHER

Product intake of oral nutrition supplement provided

Oral Nutrition Supplement C

Product containing calories from carbohydrate, protein, and fat

Group Type ACTIVE_COMPARATOR

Oral Nutrition Supplement

Intervention Type OTHER

Product intake of oral nutrition supplement provided

Oral Nutrition Supplement D

Product containing calories from carbohydrate, protein, and fat

Group Type ACTIVE_COMPARATOR

Oral Nutrition Supplement

Intervention Type OTHER

Product intake of oral nutrition supplement provided

Oral Nutrition Supplement E

Product containing calories from carbohydrate, protein, and fat

Group Type ACTIVE_COMPARATOR

Oral Nutrition Supplement

Intervention Type OTHER

Product intake of oral nutrition supplement provided

Oral Nutrition Supplement F

Product containing calories from carbohydrate, protein, and fat

Group Type ACTIVE_COMPARATOR

Oral Nutrition Supplement

Intervention Type OTHER

Product intake of oral nutrition supplement provided

Interventions

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Oral Nutrition Supplement

Product intake of oral nutrition supplement provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

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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17.11.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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