Glycemic Response in Persons With Type 2 Diabetes Mellitus

Nestlé

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Oral Nutrition Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04168541

17.11.US.HCN

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 6 patient groups

Oral Nutrition Supplement A

Active Comparator group

Description:

Product containing calories from carbohydrate, protein, and fat

Treatment:

Other: Oral Nutrition Supplement

Oral Nutrition Supplement B

Active Comparator group

Description:

Product containing calories from carbohydrate, protein, and fat

Treatment:

Other: Oral Nutrition Supplement

Oral Nutrition Supplement C

Active Comparator group

Description:

Product containing calories from carbohydrate, protein, and fat

Treatment:

Other: Oral Nutrition Supplement

Oral Nutrition Supplement D

Active Comparator group

Description:

Product containing calories from carbohydrate, protein, and fat

Treatment:

Other: Oral Nutrition Supplement

Oral Nutrition Supplement E

Active Comparator group

Description:

Product containing calories from carbohydrate, protein, and fat

Treatment:

Other: Oral Nutrition Supplement

Oral Nutrition Supplement F

Active Comparator group

Description:

Product containing calories from carbohydrate, protein, and fat

Treatment:

Other: Oral Nutrition Supplement