Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal replacement
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes
Eligibility Criteria
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
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
Meal replacement A
Meal replacement B
Meal replacement C
Meal replacement D
Meal replacement E
Meal replacement F
Arm Description
Outcomes
Primary Outcome Measures
Area under the blood glucose curve (AUC 0-240)
Secondary Outcome Measures
Area under the insulin curves (AUC 0-240)
Insulinogenic index [Change in Ins30/Change in Glu30]
AUC (0-30min) for insulin
Full Information
NCT ID
NCT03155867
First Posted
May 15, 2017
Last Updated
June 29, 2017
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT03155867
Brief Title
Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Official Title
Plasma Glucose and Insulin Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
May 18, 2017 (Actual)
Study Completion Date
May 18, 2017 (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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meal replacement A
Arm Type
Active Comparator
Arm Title
Meal replacement B
Arm Type
Active Comparator
Arm Title
Meal replacement C
Arm Type
Active Comparator
Arm Title
Meal replacement D
Arm Type
Active Comparator
Arm Title
Meal replacement E
Arm Type
Active Comparator
Arm Title
Meal replacement F
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Meal replacement
Intervention Description
The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Primary Outcome Measure Information:
Title
Area under the blood glucose curve (AUC 0-240)
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
Title
AUC (0-30min) for insulin
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 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
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
Learn more about this trial
Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
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