Back to resultsGlycemic Response in Persons With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balanced Nutritional Drink
Diabetes Specific, Balanced Nutritional Drink (DMA)
Diabetes Specific, Balanced Nutritional Drink DMB
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
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
- 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
Sites / Locations
- Orange County Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Balanced Nutritional Drink
Balanced Nutritional Drink - DMA
Balanced Nutritional Drink - DMB
Arm Description
The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.
The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.
Outcomes
Primary Outcome Measures
Area under the blood glucose curve
Area under the blood glucose curve (AUC 0-240 minutes)
Secondary Outcome Measures
Area under the insulin curves
Area under the insulin curves (AUC 0-240)
Insulinogenic index
Insulinogenic index [Change in Ins30/Change in Glu30]
Full Information
NCT ID
NCT04413357
First Posted
May 29, 2020
Last Updated
October 19, 2021
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT04413357
Brief Title
Glycemic Response in Persons With Type 2 Diabetes
Official Title
Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
June 11, 2020 (Actual)
Study Completion Date
August 11, 2020 (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 nutrition supplement interventions.
Detailed Description
This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three 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 three interventions on three 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
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balanced Nutritional Drink
Arm Type
Active Comparator
Arm Description
The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
Arm Title
Balanced Nutritional Drink - DMA
Arm Type
Active Comparator
Arm Description
The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.
Arm Title
Balanced Nutritional Drink - DMB
Arm Type
Active Comparator
Arm Description
The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.
Intervention Type
Other
Intervention Name(s)
Balanced Nutritional Drink
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)
Diabetes Specific, Balanced Nutritional Drink (DMA)
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 available in retail setting.
Intervention Type
Other
Intervention Name(s)
Diabetes Specific, Balanced Nutritional Drink DMB
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
Area under the blood glucose curve
Description
Area under the blood glucose curve (AUC 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
Description
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
Description
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
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
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
Learn more about this trial
Glycemic Response in Persons With Type 2 Diabetes
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