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Evaluation of a Nutritional Supplement for People With Type 2 Diabetes. | Clinical Trials | Clareo Health

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Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).

NCT01850134•Abbott Nutrition

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

Locations (2)

Biofortis Clinical Research

Addison, Illinois, United States

Radiant Research

Cincinnati, Ohio, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

July 13, 2016

Conditions

Diabetes

Interventions

Experimental Study Product

OTHER

Control Study Product

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

Inclusion Criteria

Exclusion Criteria

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