Research with human participants

Overview of medical research in the Netherlands

Improving clinical care of diabetes mellitus; randomized clinical trial

No registrations found.

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Ethical review
Positive opinion
Status
Other
Health condition type
-
Study type
Interventional

ID

NL-OMON23763

Source

NTR

Brief title

Met_AA trial

Health condition

Diabetes Mellitus

Sponsors and support

Primary sponsor :
Government hospital
Community diabetes clinic
Source(s) of monetary or material Support :
Self-financed research

Intervention

Outcome measures

Primary outcome

a. improved glucose tolerance

b. Reduction in lipid profiling

Secondary outcome

a. 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.

Study objective

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.

Study design

0 months

3 months

6 months

12 months

Intervention

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

Public
Taibah University

Syed Wasif Gillani
KSA

[default]
The Netherlands
wasifgillani@gmail.com
Scientific
Taibah University

Syed Wasif Gillani
KSA

[default]
The Netherlands
wasifgillani@gmail.com

Inclusion criteria

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.

Exclusion criteria

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.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active

Recruitment

NL
Recruitment status
:
Other
Start date (anticipated) :
Enrollment :
300
Type :
Unknown

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL5920
NTR-old NTR6100
Other 10-776-6941 : NMRR

Summary results

In Process - Featuring Diabetic Care with Ascorbic Acid & Acetylsalicylic Acid; A Randomized Single Blind Control Trial