NCT00992043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 23, 2010

Status Verified

October 1, 2009

First QC Date

October 7, 2009

Last Update Submit

March 22, 2010

Conditions

DiabetesRenal Function

Keywords

creatine supplementationexercise training

Outcome Measures

Primary Outcomes (1)

  • glycated hemoglobin

    three months

Study Arms (2)

exercise and placebo

PLACEBO COMPARATOR
Dietary Supplement: creatineOther: Exercise training

exercise and creatine

EXPERIMENTAL
Dietary Supplement: creatineOther: Exercise training

Interventions

creatineDIETARY_SUPPLEMENT
exercise and creatineexercise and placebo
Exercise trainingOTHER
exercise and creatineexercise and placebo

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital - School of Medicine - University of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 21999299DERIVED

  • 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.

    PMID: 20976468DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

CreatineExercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bruno Gualano, PhD ongoing

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

October 1, 2009

Study Completion

January 1, 2010

Last Updated

March 23, 2010

Record last verified: 2009-10

Locations

BR(1)