Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Enteral Nutrition Formula

• Registration Number: NCT02898766
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enteral Nutrition Formula 1	Enteral Nutrition Formula	Enteral Nutrition Formula
Enteral Nutrition Formula 2	Enteral Nutrition Formula	Enteral Nutrition Formula

Primary Outcome Measures

Name	Time	Method
Area under the blood glucose curve (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Orange County Research Center; 🇺🇸 Tustin, California, United States