Glucose Response in Persons with Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Oral nutrition supplement - test; Other: Oral nutrition supplement - control

• Registration Number: NCT04914559
• 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: 2021-05-17
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-04
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• 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

Arm && Interventions

Group	Intervention	Description
Oral Nutrition Supplement Test	Oral nutrition supplement - test	The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.
Oral Nutrition Supplement Control	Oral nutrition supplement - control	The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.

Primary Outcome Measures

Name	Time	Method
Area under the blood glucose curve	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
Insulinogenic index	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	Insulinogenic index (change in Ins30/change in Glu30)
Area under the insulin curve	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	Area under the insulin curve (AUC 0-240 minutes)

Trial Locations

Locations (1)

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