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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Abbott Nutrition
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01850134
First received: May 7, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted

May 7, 2013
May 7, 2013
June 2013
July 2013   (final data collection date for primary outcome measure)
Hunger [ Time Frame: Treatment Visit 1 and Treatment Visit 2 ] [ Designated as safety issue: No ]
An appetite questionnaire evaluating change from baseline during each study visit.
Same as current
No Changes Posted
  • Fullness [ Time Frame: Treatment Visit 1 and Treatment Visit 2 ] [ Designated as safety issue: No ]
    An appetite questionnaire evaluating change from baseline during each study visit.
  • Desire to Eat [ Time Frame: Treatment Visit 1 and Treatment Visit 2 ] [ Designated as safety issue: No ]
    An appetite questionnaire evaluating change from baseline during each study visit.
  • Prospective Consumption [ Time Frame: Treatment Visit 1 and Treatment Visit 2 ] [ Designated as safety issue: No ]
    An appetite questionnaire evaluating change from baseline during each study visit.
Same as current
Not Provided
Not Provided
 
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes
  • Other: Experimental Study Product
    Other Name: Oral nutritional supplement for people with Diabetes.
  • Other: Control Study Product
    Other Name: Water beverage.
  • Placebo Comparator: Control Study Product
    1 serving of control beverage.
    Intervention: Other: Control Study Product
  • Experimental: Experimental Study Product
    1 serving of a nutritional supplement for people with diabetes.
    Intervention: Other: Experimental Study Product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
54
July 2013
July 2013   (final data collection date for primary outcome measure)

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 > 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.
Both
18 Years to 75 Years
Yes
Contact: Kristen DeLuca, MS, RD, LD 614-624-5455 kristen.deluca@abbott.com
Contact: Bobbie Swearengin, RN 614-624-7182 bobbie.swearengin@abbott.com
United States
 
NCT01850134
BL18
No
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Amy Devitt-Maicher, PhD Abbott Nutrition
Abbott Nutrition
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP