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

April 24, 2009 updated by: Abbott Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Provident Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Radiant Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. uses injected medications (e.g., insulin, exenatide) for glucose control.
  2. history of diabetic ketoacidosis
  3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
  4. active malignancy
  5. 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.
  6. end stage organ failure
  7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
  8. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
  10. symptomatic in response to blood collection prior to enrollment into this study.
  11. clotting or bleeding disorders.
  12. non-typical eating pattern
  13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
  14. engages in strenuous exercise five or more times per week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake
Other: Nutritional Formula
nutritional shake daily
Active Comparator: A2
Usual diet
Other: Usual diet
usual dietary habits
Experimental: A3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average daily blood glucose level
Time Frame: 11 days
11 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Director: Vikkie Mustad, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Estimate)

April 27, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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