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OpenTrials
Completed

NCT Number: NCT00753181

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

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.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Provident Clinical Research, Bloomington, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Formula

Other

nutritional shake daily

Usual diet

Other

usual dietary habits

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

Primary outcomes

  1. Average daily blood glucose level

    Time frame: 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

    Time frame: 11 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 16, 2008
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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