Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Aug 2016
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 11, 2016
September 1, 2016
2 months
September 8, 2016
October 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the blood glucose curve (AUC 0-240)
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary Outcomes (3)
Area under the insulin curves (AUC 0-240)
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index (Ins30/(Glu30))
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
AUC (0-30min) for insulin
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Study Arms (2)
Enteral Nutrition Formula 1
ACTIVE COMPARATOREnteral Nutrition Formula
Enteral Nutrition Formula 2
ACTIVE COMPARATOREnteral Nutrition Formula
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orange County Research Center
Tustin, California, 92780, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Neutel, MD
Orange County Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 13, 2016
Study Start
August 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 11, 2016
Record last verified: 2016-09