Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

Completed · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).

Key facts

Study ID

NCT01324921

Run by

Abbott Nutrition

People needed

37

Starts

2010-08-01

Expected to finish

2010-09-01

Last updated by the study team

2011-03-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• type 2 diabetes
• between 21 and 75 years of age
• male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
• BMI is > 18.5 kg/m2 and <35 kg/m2
• If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.

You may not qualify if…

• Hemoglobin A1c value at screening of greater than or equal to 9%.
• Uses exogenous insulin or exenatide for glucose control.
• type 1 diabetes.
• history of diabetic ketoacidosis.
• current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
• active malignancy
• significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
• end-stage organ failure or is status post organ transplant.
• history of renal disease.
• current hepatic disease.
• history of severe gastroparesis.
• chronic, contagious, infectious disease
• taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
• clotting or bleeding disorders
• allergic or intolerant to any ingredient found in the study products.
• habitual user of tobacco products (

Where it is running

• Provident Clinical Research and Consulting LLC — Glen Ellyn, Illinois, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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