a. 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…
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus
Ondersteuning
Community diabetes clinic
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
a. improved glucose tolerance <br>
b. Reduction in lipid profiling
Doel van het onderzoek
a. 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.
Onderzoeksopzet
0 months
3 months
6 months
12 months
Onderzoeksproduct en/of interventie
a. 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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
a. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
a. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5920 |
| NTR-old | NTR6100 |
| Ander register | 10-776-6941 : NMRR |