Evaluation of a Nutritional Product for People With Type 2 Diabetes

Diabetes Clinical Trial

Official title:

Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850810
• Other study ID #: BL17
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: March 2, 2015
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: March 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Diagnosis of Type 2 Diabetes.

2. Age between 18 and 75 years.

3. HbA1c > 6.0 but = 8.5

4. 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.

5. BMI is > 18.5 kg/m2 and < 40.0 kg/m2.

6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.

7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

• Subjects will be excluded from the study if they meet any of the following criteria:

1. Use of exogenous insulin or GLP-1 agonists for glucose control.

2. Diagnosis of Type 1 diabetes.

3. History of diabetic ketoacidosis.

4. 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.

5. Active malignancy.

6. Significant cardiovascular event < 12 weeks prior to study entry.

7. End stage organ failure or status post organ transplant.

8. Active metabolic, hepatic, or gastrointestinal disease.

9. Chronic, contagious, infectious disease.

10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.

11. History of fainting or other adverse reactions in response to blood collection.

12. Clotting or bleeding disorders.

13. Allergy or intolerance to study product ingredient.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Experimental Study Product

• Control Study Product

Locations

Country	Name	City	State
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hunger	An appetite questionnaire administered 0 to 300 minutes during each study visit.	Treatment Visit Week 1 and Treatment Visit Week 2	No
Secondary	Fullness	An appetite questionnaire administered 0 to 300 minutes during each study visit.	Treatment Visit Week 1 and Treatment Visit Week 2	No
Secondary	Desire to Eat	An appetite questionnaire administered 0 to 300 minutes during each study visit.	Treatment Visit Week 1 and Treatment Visit Week 2	No
Secondary	Prospective Consumption	An appetite questionnaire administered 0 to 300 minutes during each study visit.	Treatment Visit Week 1 and Treatment Visit Week 2	No