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An Intervention Program to Control Diabetes

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00543621
First received: October 12, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose
Study to evaluate the effectiveness of a structured intervention to improve diabetes control.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Intervention Program to Control Diabetes

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • HbA1c, Fasting blood glucose,blood pressure, weight loss [ Time Frame: 24 weeks ]
Enrollment: 150
Study Start Date: May 2005
  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

ClinicalTrials.gov Identifier: NCT00543621     History of Changes
Other Study ID Numbers: Welltech Study 
Study First Received: October 12, 2007
Last Updated: October 12, 2007
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on September 26, 2016