Glycemic Response in Persons With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413357
• Other study ID #: 19.01.US.HCN
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: August 11, 2020

Study information

• Verified date: May 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Balanced Nutritional Drink
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
• Diabetes Specific, Balanced Nutritional Drink (DMA)
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.
• Diabetes Specific, Balanced Nutritional Drink DMB
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.

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	Area under the blood glucose curve (AUC 0-240 minutes)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary	Area under the insulin curves	Area under the insulin curves (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary	Insulinogenic index	Insulinogenic index [Change in Ins30/Change in Glu30]	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes