search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Improving clinical care of diabetes mellitus; randomized clinical trial


- candidate number25435
- NTR NumberNTR6100
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-okt-2016
- Secondary IDsNMRR 10-776-6941
- Public TitleImproving clinical care of diabetes mellitus; randomized clinical trial
- Scientific TitleImpact of Ascorbic acid and Acetylsalicylic acid on the relative outcome of diabetes mellitus; multicenter single blinded randomized control trial
- ACRONYMMet_AA trial
- hypothesisa. Ascorbic acid in combination with metformin (500mg BD) improve the glucose tolerance with a daily dose of 500mg over a period of 12 months.
b. Ascorbic acid with metformin reduce the adverse effects/events.
c. Acetylesalicylic acid in combination with metformin (500mg BD) improve the glucose tolerance with a daily dose of 100mg over a period of 12 months.
d. Acetylsalicylic acid with metformin reduce the adverse effects/events.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus
- Inclusion criteriaa. patient age more than 18years
b. diagnose with diabetes mellitus type 2 not more than 5 years
c. both male/female
d. prescribed with metformin 500mg BD dosing
e. glucose intolerance with last 3 reading of FBS or SBG
f. HbA1c more than 7% with minimum last 6 months
g. only diagnosed with diabetes mellitus type 2.
- Exclusion criteriaa. patient with age less than 18 years
b. diabetes history of more than 5 years
c. transexual
d. metformin dose more than 1 g/day or in-combination
e. HbA1c less than 7% with last two readings
f. patients with another systemic complications except diabetes mellitus type 2.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2015
- planned closingdate30-okt-2017
- Target number of participants300
- Interventionsa. control arm - metformin (500mgBD) usual dose
b. Group 1 - randomized - metformin (500mgBD) + Ascobic acid (500mg OD) - for 12 months

c. Group 2 - randomized - metformin (500mg BD) + Acetylsalicylic acid (100mg OD) for 12 months
- Primary outcomea. improved glucose tolerance
b. Reduction in lipid profiling
- Secondary outcomea. Reduction in diabetes related complications over a period of 12 months
b. Improved clinical outcomes in lipid profiling.
c. comparison between Ascorbic acid Vs Acetylsalicylic acid combination with metformin.
- Timepoints0 months
3 months
6 months
12 months
- Trial web sitenone
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESDr. Syed Wasif Gillani
- CONTACT for SCIENTIFIC QUERIESDr. Syed Wasif Gillani
- Sponsor/Initiator General Hospital Penang
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsIn Process - Featuring Diabetic Care with Ascorbic Acid & Acetylsalicylic Acid; A Randomized Single Blind Control Trial
- Brief summary
- Main changes (audit trail)
- RECORD20-okt-2016 - 25-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl