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

Diabetes Clinical Trial

Official title:

Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898766
• Other study ID #: 16.17.CLI
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: October 10, 2016
• Start date: August 2016
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Enteral Nutrition Formula

Locations

Country	Name	City	State
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the blood glucose curve (AUC 0-240)		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	No
Secondary	Area under the insulin curves (AUC 0-240)		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	No
Secondary	Insulinogenic index (Ins30/(Glu30))		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	No
Secondary	AUC (0-30min) for insulin		Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	No