Effects of Nutritional Products on Blood Glucose in Sub...

Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

This study is currently recruiting participants.
Verified by Abbott Nutrition, September 2008
Sponsored by: Abbott Nutrition

Information provided by: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00753181

Purpose
To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Other: Nutritional Formula
Other: Usual diet
Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
Phase III

MedlinePlus related topics: Diabetes Tremor
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
Average daily blood glucose level [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Estimated Enrollment:60
Study Start Date:August 2008
Estimated Study Completion Date:February 2009
Estimated Primary Completion Date:December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A1: Experimental
Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake Other: Nutritional Formula
nutritional shake daily
A2: Active Comparator
Usual diet Other: Usual diet
usual dietary habits
A3: Experimental
Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars. Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
nutritional shake, diabetes specific cereal and diabetes snack bar daily

Eligibility
Ages Eligible for Study:18 Years to 75 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
Inclusion Criteria:

type 2 diabetes
HbA1c >6.5% and <11.0%
male/non-pregnant, non-lactating female, at least 6 months postpartum
if female of childbearing potential, practicing method of birth control
Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m2.
weight stable for past two months
if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months
Exclusion Criteria:

uses injected medications (e.g., insulin, exenatide) for glucose control.
history of diabetic ketoacidosis
current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
active malignancy
states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
end stage organ failure
active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
symptomatic in response to blood collection prior to enrollment into this study.
clotting or bleeding disorders.
non-typical eating pattern
is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
engages in strenuous exercise five or more times per week.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753181

Contacts
Contact: Bobbie Swearengin, RN 614 624 7182 Bobbie.Swearengin@abbott.com

Locations
United States, Indiana
Provident Clinical Research Recruiting
Bloomington, Indiana, United States, 47403
Principal Investigator: Kevin C Maki, PhD
United States, Ohio
Radiant Research Recruiting
Cincinnati, Ohio, United States, 45242
Principal Investigator: Michael J Noss, MD

Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Director: Vikkie Mustad, PhD Abbott Nutrition

Responsible Party:Abbott Nutrition ( Bobbie Swearengin, Director Clinical Research Operations )
Study ID Numbers:BK21
First Received:September 12, 2008
Last Updated:September 12, 2008
ClinicalTrials.gov Identifier:NCT00753181 [history]
Health Authority:United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders