Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Nestlé

Status: Completed

Conditions: Diabetes

Treatments: Other: Meal replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT03155867

16.11.US.HCN

Details and patient eligibility

About

This will be a randomized, cross-over design. Subjects will be randomized to one of six interventions on six separate study days, 1 week apart.

Enrollment: 13 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20-75 yrs
• Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg
• Hematocrit levels within normal limits

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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13 participants in 6 patient groups

Meal replacement A

Active Comparator group

Treatment:

Other: Meal replacement

Meal replacement B

Active Comparator group

Treatment:

Other: Meal replacement

Meal replacement C

Active Comparator group

Treatment:

Other: Meal replacement

Meal replacement D

Active Comparator group

Treatment:

Other: Meal replacement

Meal replacement E

Active Comparator group

Treatment:

Other: Meal replacement

Meal replacement F

Active Comparator group

Treatment:

Other: Meal replacement