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
  Purpose

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


Condition Intervention
Diabetes
Other: Experimental Study Product
Other: Control Study Product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 54
Study Start Date: June 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Study Product
1 serving of control beverage.
Other: Control Study Product
Other Name: Water beverage.
Experimental: Experimental Study Product
1 serving of a nutritional supplement for people with diabetes.
Other: Experimental Study Product
Other Name: Oral nutritional supplement for people with Diabetes.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850134

Contacts
Contact: Kristen DeLuca, MS, RD, LD 614-624-5455 kristen.deluca@abbott.com
Contact: Bobbie Swearengin, RN 614-624-7182 bobbie.swearengin@abbott.com

Locations
United States, Illinois
Biofortis Clinical Research Not yet recruiting
Addison, Illinois, United States, 60101
Principal Investigator: Andrea Lawless, MD         
United States, Ohio
Radiant Research Not yet recruiting
Cincinnati, Ohio, United States, 45249
Principal Investigator: Michael Noss, MD         
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Amy Devitt-Maicher, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01850134     History of Changes
Other Study ID Numbers: BL18
Study First Received: May 7, 2013
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014