Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetes

In brief

The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.

Key facts

Study ID

NCT01850134

Run by

Abbott Nutrition

People needed

0

Starts

2013-06-01

Expected to finish

2013-07-01

Last updated by the study team

2016-07-13

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 > 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

• Biofortis Clinical Research — Addison, Illinois, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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