NCT00753181

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

September 12, 2008

Last Update Submit

April 24, 2009

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Average daily blood glucose level

    11 days

Secondary Outcomes (1)

  • 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

    11 days

Study Arms (3)

A1

EXPERIMENTAL

Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake

Other: Nutritional Formula

A2

ACTIVE COMPARATOR

Usual diet

Other: Usual diet

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.

Interventions

Nutritional FormulaOTHER

nutritional shake daily

A1
Usual dietOTHER

usual dietary habits

A2
Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.OTHER

nutritional shake, diabetes specific cereal and diabetes snack bar daily

A3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Provident Clinical Research

Bloomington, Indiana, 47403, United States

Location

Radiant Research

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vikkie Mustad, PhD

    Abbott Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 16, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

April 27, 2009

Record last verified: 2009-04

Locations

US(2)