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An Intervention Program to Control Diabetes

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ClinicalTrials.gov Identifier: NCT00543621
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : October 15, 2007
Sponsor:
Information provided by:
Abbott Nutrition

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Study to evaluate the effectiveness of a structured intervention to improve diabetes control.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: daily enteral nutritional product and/or behavioral changes Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Intervention Program to Control Diabetes
Study Start Date : May 2005
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HbA1c, Fasting blood glucose,blood pressure, weight loss [ Time Frame: 24 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • informed consent
  • 18-70 adults
  • Type 2 Diabetes
  • Males and non-pregnant females

Exclusion Criteria:

  • Use of exogenous insulin for glucose control
  • Use of medications or supplements for weight loss
  • Advanced diabetes complications
  • Recent history of cardiovascular event
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543621


Locations
China
Huandong Hospital
Shanghai, China
Sponsors and Collaborators
Abbott Nutrition
Investigators
Principal Investigator: Jianqin Sun, MD, MPH Clinical Nutrition Center, Huadong Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00543621     History of Changes
Other Study ID Numbers: Welltech Study
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: October 15, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases