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Glycemic Response in Adults With Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance oral nutritional drink - control
Balance oral nutritional drink - test
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

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/dl
  • 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
  • Patients with anemia
  • 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
  • Patients with anemia
  • Currently participating in another clinical trial

Sites / Locations

  • Orange County Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Active Comparator: Oral Nutrition Supplement Control

Active Comparator: Oral Nutrition Supplement Test

Arm Description

The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.

The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.

Outcomes

Primary Outcome Measures

Post-prandial glycemic markers
Area under the blood glucose curve (AUC 0-240 minutes)

Secondary Outcome Measures

Post-prandial insulin markers
Area under the insulin curve (AUC 0-240 minutes)
Insulinogenic index
Insulinogenic index (change in Ins30/change in Glu30)

Full Information

First Posted
August 24, 2021
Last Updated
October 20, 2021
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT05026424
Brief Title
Glycemic Response in Adults With Diabetes
Official Title
Glucose and Insulin Response in Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 5, 2021 (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
No

5. Study Description

Brief Summary
This will be a randomized crossover design with oral nutrition supplement interventions.
Detailed Description
This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two 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 two interventions on two separate study days, one week apart.
Masking
Participant
Masking Description
Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Oral Nutrition Supplement Control
Arm Type
Placebo Comparator
Arm Description
The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.
Arm Title
Active Comparator: Oral Nutrition Supplement Test
Arm Type
Active Comparator
Arm Description
The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.
Intervention Type
Other
Intervention Name(s)
Balance oral nutritional drink - control
Intervention Description
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
Intervention Type
Other
Intervention Name(s)
Balance oral nutritional drink - test
Intervention Description
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
Primary Outcome Measure Information:
Title
Post-prandial glycemic markers
Description
Area under the blood glucose curve (AUC 0-240 minutes)
Time Frame
[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Secondary Outcome Measure Information:
Title
Post-prandial insulin markers
Description
Area under the insulin curve (AUC 0-240 minutes)
Time Frame
[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Title
Insulinogenic index
Description
Insulinogenic index (change in Ins30/change in Glu30)
Time Frame
[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
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/dl 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 Patients with anemia 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 Patients with anemia Currently participating in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krysmaru Araujo Torres, MD
Organizational Affiliation
Nestle Health Science
Official's Role
Study Director
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

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Glycemic Response in Adults With Diabetes

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