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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02898766

Enrollment

Registered

2016-09-13

Start date

2016-08-31

Completion date

2016-10-31

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

OTHEREnteral Nutrition Formula

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Insulinogenic index (Ins30/(Glu30))	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Area under the insulin curves (AUC 0-240)	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026