Glycemic Response in Persons with Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Balanced Nutritional Drink; Other: Diabetes Specific, Balanced Nutritional Drink (DMA); Other: Diabetes Specific, Balanced Nutritional Drink DMB

• Registration Number: NCT04413357
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-02
• Primary Completion: 2020-06-11
• Study Completion: 2020-08-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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
• 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
• 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, soy 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
• Patients with anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Balanced Nutritional Drink	Balanced Nutritional Drink	The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
Balanced Nutritional Drink - DMA	Diabetes Specific, Balanced Nutritional Drink (DMA)	The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.
Balanced Nutritional Drink - DMB	Diabetes Specific, Balanced Nutritional Drink DMB	The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.

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 curves	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes	Area under the insulin curves (AUC 0-240)

Trial Locations

Locations (1)

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