DiabetesNCT00992043
Creatine Supplementation and Diabetes
A study testing creatine and Exercise training in people with Diabetes and Renal Function, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes, Renal Function
- What is being tested?
- creatine and Exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital - School of Medicine - University of Sao Paulo
São Paulo, São Paulo, 05508-030
About this study
Official title: 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.
- Conditions
- Diabetes, Renal Function
- Being tested
- creatine, Exercise training
- Keywords
- creatine supplementation, exercise training
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatineDietary supplement
Exercise trainingOther
| Study group | Role | What they receive |
|---|---|---|
| exercise and placebo | Placebo comparator | Not described Receives: Dietary Supplement: creatine; Other: Exercise training |
| exercise and creatine | Experimental | Not described Receives: Dietary Supplement: creatine; Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Gualano, PhD ongoing, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992043
- Sponsor's protocol ID
- eefeusp2
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 23 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21999299Gualano 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.
PubMed 20976468
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Creatine Supplementation Combined With Exercise Training in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00992043
- Acronym / sponsor ID
- eefeusp2
- Conditions
- Diabetes, Renal Function
- Keywords
- creatine supplementation, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2009
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise and placebo | Placebo comparator | Dietary Supplement: creatine, Other: Exercise training |
| exercise and creatine | Experimental | Dietary Supplement: creatine, Other: Exercise training |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- males and females type 2 diabetic patients
- glycated hemoglobin between > 9%
- non insulin users
- physically inactive
- only metformin and/or sulfonylurea users
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creatine | Dietary supplement | exercise and creatine, exercise and placebo |
| Exercise training | Other | exercise and creatine, exercise and placebo |
Primary outcome
glycated hemoglobin
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
- Derived from this study: PubMed 21999299Gualano 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.
- Derived from this study: PubMed 20976468Gualano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Gualano, PhD ongoing principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine and Exercise training in people with Diabetes and Renal Function, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992043, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2010.