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Glycemic Response in Persons With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Nutrition Supplement
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subject inclusion criteria

All subjects must comply with all the following 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

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

  • 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

Sites / Locations

  • Orange County Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oral Nutrition Supplement A

Oral Nutrition Supplement B

Oral Nutrition Supplement C

Oral Nutrition Supplement D

Oral Nutrition Supplement E

Oral Nutrition Supplement F

Arm Description

Product containing calories from carbohydrate, protein, and fat

Product containing calories from carbohydrate, protein, and fat

Product containing calories from carbohydrate, protein, and fat

Product containing calories from carbohydrate, protein, and fat

Product containing calories from carbohydrate, protein, and fat

Product containing calories from carbohydrate, protein, and fat

Outcomes

Primary Outcome Measures

Area under the blood glucose curve (ACU 0-240 minutes)

Secondary Outcome Measures

Area under the insulin curves (AUC 0-240)
Insulinogenic index [Change in Ins30/Change in Glu30]

Full Information

First Posted
February 1, 2018
Last Updated
November 18, 2019
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT04168541
Brief Title
Glycemic Response in Persons With Type 2 Diabetes Mellitus
Official Title
Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Nutrition Supplement A
Arm Type
Active Comparator
Arm Description
Product containing calories from carbohydrate, protein, and fat
Arm Title
Oral Nutrition Supplement B
Arm Type
Active Comparator
Arm Description
Product containing calories from carbohydrate, protein, and fat
Arm Title
Oral Nutrition Supplement C
Arm Type
Active Comparator
Arm Description
Product containing calories from carbohydrate, protein, and fat
Arm Title
Oral Nutrition Supplement D
Arm Type
Active Comparator
Arm Description
Product containing calories from carbohydrate, protein, and fat
Arm Title
Oral Nutrition Supplement E
Arm Type
Active Comparator
Arm Description
Product containing calories from carbohydrate, protein, and fat
Arm Title
Oral Nutrition Supplement F
Arm Type
Active Comparator
Arm Description
Product containing calories from carbohydrate, protein, and fat
Intervention Type
Other
Intervention Name(s)
Oral Nutrition Supplement
Intervention Description
Product intake of oral nutrition supplement provided
Primary Outcome Measure Information:
Title
Area under the blood glucose curve (ACU 0-240 minutes)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary Outcome Measure Information:
Title
Area under the insulin curves (AUC 0-240)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Title
Insulinogenic index [Change in Ins30/Change in Glu30]
Time Frame
[Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject inclusion criteria All subjects must comply with all the following 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 Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Neutel, MD
Organizational Affiliation
Orange County Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Glycemic Response in Persons With Type 2 Diabetes Mellitus

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