Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - 75
Updated:8/12/2016
Start Date:July 2016
End Date:September 2016
Contact:Kemuel Reyes
Email:Kemuel.Reyes@us.nestle.com
Phone:973-765-1548

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

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

Following consent, subjects will be randomized to one of three arms. After an overnight fast
an intravenous line will be placed for blood withdrawal. The subject will then consume the
randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn
at specified intervals after the product has been consumed.

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 alphaglucosidase inhibitors such as acarbose
(Precose) and miglitol (Glyset)

- Hemoglobin A1C less than 9.0%

- Fasting blood glucose less than 180 mg

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

- Patients 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.
We found this trial at
1
site
Tustin, California
Phone: 714-550-9990
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Tustin, CA
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