- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992043
Creatine Supplementation and Diabetes
March 22, 2010 updated by: University of Sao Paulo
Efficacy and Safety of Creatine Supplementation Combined With Exercise Training in Type 2 Diabetic Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sao Paulo, Brazil, 05508-030
- General Hospital - School of Medicine - University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: exercise and placebo
|
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Experimental: exercise and creatine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glycated hemoglobin
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Gualano, PhD ongoing, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gualano B, Lugaresi R, de Salles Painelli V, Queiroz AC, Artioli G, Roschel H, Otaduy MC, Leite Cda C, Lancha AH Jr. Creatine supplementation does not augment muscle carnosine content in type 2 diabetic patients. Appl Physiol Nutr Metab. 2011 Oct;36(5):764-7. doi: 10.1139/h11-083. Erratum In: Appl Physiol Nutr Metab. 2012 Aug;37(4):809. Painelli de Salles, Vitor [corrected to de Salles Painelli, Vitor].
- Gualano B, de Salles Painelli V, Roschel H, Lugaresi R, Dorea E, Artioli GG, Lima FR, da Silva ME, Cunha MR, Seguro AC, Shimizu MH, Otaduy MC, Sapienza MT, da Costa Leite C, Bonfa E, Lancha Junior AH. Creatine supplementation does not impair kidney function in type 2 diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial. Eur J Appl Physiol. 2011 May;111(5):749-56. doi: 10.1007/s00421-010-1676-3. Epub 2010 Oct 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 7, 2009
First Posted (Estimate)
October 8, 2009
Study Record Updates
Last Update Posted (Estimate)
March 23, 2010
Last Update Submitted That Met QC Criteria
March 22, 2010
Last Verified
October 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- eefeusp2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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