Glycemic Response in Persons With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168541
• Other study ID #: 17.11.US.HCN
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: April 18, 2018

Study information

• Verified date: November 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Subject inclusion criteria

All subjects must comply with all the following 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

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

• 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:
• Oral Nutrition Supplement
Product intake of oral nutrition supplement provided

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