Evaluation of a Nutritional Product for People With Type 2 Diabetes
Completed · Not applicable
Conditions studied: Diabetes
In brief
The objective of this trial is to evaluate a nutritional product for people with Diabetes.
Key facts
- Study ID
- NCT01850810
- Run by
- Abbott Nutrition
- People needed
- 33
- Starts
- 2013-05-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2015-03-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- Diagnosis of Type 2 Diabetes.
- Age between 18 and 75 years.
- HbA1c > 6.0 but ≤ 8.5
- If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
- BMI is > 18.5 kg/m2 and < 40.0 kg/m2.
- Chronic medication dosage must be stable for at least two months prior to Screening Visit.
- Subject states that they are a habitual consumer of a morning meal.
You may not qualify if…
- Subjects will be excluded from the study if they meet any of the following criteria:
- Use of exogenous insulin or GLP-1 agonists for glucose control.
- Diagnosis of Type 1 diabetes.
- History of diabetic ketoacidosis.
- Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
- Active malignancy.
- Significant cardiovascular event < 12 weeks prior to study entry.
- End stage organ failure or status post organ transplant.
- Active metabolic, hepatic, or gastrointestinal disease.
- Chronic, contagious, infectious disease.
- Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
- History of fainting or other adverse reactions in response to blood collection.
- Clotting or bleeding disorders.
- Allergy or intolerance to study product ingredient.
Where it is running
- Radiant Research — Chicago, Illinois, United States
- Radiant Research — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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