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Creatine Supplementation and Diabetes

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00992043
First received: October 7, 2009
Last updated: March 22, 2010
Last verified: October 2009
History of Changes
  Purpose

Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The researchers aim to investigate whether this supplement can affect metabolic control in diabetic patients.


Condition Intervention
Diabetes
Renal Function
 Dietary Supplement: creatine
Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Creatine Supplementation Combined With Exercise Training in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • glycated hemoglobin [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2009
Study Completion Date: January 2010
Arms Assigned Interventions
Placebo Comparator: exercise and placebo Dietary Supplement: creatine Other: Exercise training
Experimental: exercise and creatine Dietary Supplement: creatine Other: Exercise training

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and females type 2 diabetic patients
  • glycated hemoglobin between > 9%
  • non insulin users
  • physically inactive
  • only metformin and/or sulfonylurea users
  • BMI > 30 kg/m2
  • age of years > 50 y
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992043

Locations
Brazil
General Hospital - School of Medicine - University of Sao Paulo
Sao Paulo, Brazil, 05508-030
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Bruno Gualano, PhD ongoing University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00992043     History of Changes
Other Study ID Numbers: eefeusp2
Study First Received: October 7, 2009
Last Updated: March 22, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
creatine supplementation
exercise training

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

ClinicalTrials.gov processed this record on June 18, 2013