Glycemic Response in Adults with Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT05026424
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This will be a randomized crossover design with oral nutrition supplement interventions.

Detailed Description

This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Study Timeline

• Study Start: 2021-08-02
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age 20-75 years
• Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg/dl
• Hematocrit levels within normal limits
• Having obtained his/her informed consent

Exclusion Criteria

• Abnormal thyroid function
• Creatinine >2.0 mg/dl
• Potassium <3.5 mEq/l
• Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
• Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
• Patients with anemia
• Current insulin therapy or insulin therapy within the past month
• Patient who are pregnant
• Allergies to milk, soy or any component of the test product
• Patient who in the investigators assessment cannot be expected to comply with treatment
• Patients with anemia
• Currently participating in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Post-prandial glycemic markers	[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]	Area under the blood glucose curve (AUC 0-240 minutes)

Secondary Outcome Measures

Name	Time	Method
Post-prandial insulin markers	[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]	Area under the insulin curve (AUC 0-240 minutes)
Insulinogenic index	[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]	Insulinogenic index (change in Ins30/change in Glu30)

Trial Locations

Locations (1)

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