Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enteral Nutrition Formula
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/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg
Exclusion Criteria:
- Abnormal thyroid function
- Creatinine >2.0 mg/dL
- Potassium <3.5 mEq/L
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
- Patients currently on any anti-coagulant medication
- 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, fish oil 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.
Sites / Locations
- Orange County Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Enteral Nutrition Formula 1
Enteral Nutrition Formula 2
Arm Description
Enteral Nutrition Formula
Enteral Nutrition Formula
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 (Ins30/(Glu30))
AUC (0-30min) for insulin
Full Information
NCT ID
NCT02898766
First Posted
September 8, 2016
Last Updated
October 10, 2016
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT02898766
Brief Title
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Official Title
Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two 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
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enteral Nutrition Formula 1
Arm Type
Active Comparator
Arm Description
Enteral Nutrition Formula
Arm Title
Enteral Nutrition Formula 2
Arm Type
Active Comparator
Arm Description
Enteral Nutrition Formula
Intervention Type
Other
Intervention Name(s)
Enteral Nutrition Formula
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 (Ins30/(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/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
Hemoglobin A1C less than 9.0%
Fasting blood glucose less than 180 mg
Exclusion Criteria:
Abnormal thyroid function
Creatinine >2.0 mg/dL
Potassium <3.5 mEq/L
Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
Patients currently on any anti-coagulant medication
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, fish oil 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.
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 Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
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