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Reducing Metabolic risk associated with coronary artery disease; controlling dietary components in diabetes patients.


- candidate number25548
- NTR NumberNTR6211
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2016
- Secondary IDsProtocol ID PML:280916
- Public TitleReducing Metabolic risk associated with coronary artery disease; controlling dietary components in diabetes patients.
- Scientific TitleMetabolic Syndrome and dietary components are associated with coronary artery disease risk score in diabetes mellitus patients: a multicenter controlled trials.
- ACRONYMMSDC-PAK
- hypothesiscontrolling diet will reduce metabolic syndrome in diabetes patients controlling metabolic syndrome will reduce the risk of coronary artery disease risk score.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus
- Inclusion criteriaindividuals over the age of 18, of both genders, with at least one of the Metabolic Syndrome components and/or comorbities
- Exclusion criteriawithout metabolic or motor disabilities that would limit physical exercise
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 20-dec-2016
- planned closingdate30-mei-2017
- Target number of participants500
- InterventionsControl Arm
Participants randomized into the control group did not receive unsolicited feedback but will continue to receive their usual medical care as per usual when visiting their doctors but are allowed to contact the research facilitator as necessary. Participants in all three groups were required to monitor their blood glucose at least once daily (as per schedule). Glucose readings were taken daily as per schedule and performed 5 days a week throughout the six-months of study duration. At the end of study (six-months) participants of control arm were compared with Pharmacist intervention arm and telemonitoring arm for glycemic control and other relevant outcomes.

Pharmacist Intervention Arm:
Participants were referred through their primary physician or clinic nurses. Further screening was conducted to ensure eligibility for participation in this study.
Diabetes education that includes (i) diabetes disease process (ii) nutrition and physical exercise (iii) self-monitoring (iv) diabetes complications will be provided to participants who have provided a written informed consent. Participant baseline assessment included (i) past medical history (ii) demographic questionnaire and symptom questionnaire (iii) concomitant medication (iv) physical examination such as weight, height (v) blood specimen including HbA1c, etc.
Eligible participants were provided with a systemic booklet and home-work book to record their daily activities. Also researcher has developed a weekly glucose-monitoring schedule. Participants have to report daily physical activity and eating habits as well. A registered pharmacist provide once weekly visit to participant home for monitoring and evaluation (also provide counselling).
- Primary outcomeArterial Blood Pressure
Lipid Profiling
Risk of Coronary Artery disease score
- Secondary outcomeMetabolic syndrome
Dietary assessment
- Timepoints0 - 2 - 4 - 6 months
- Trial web sitenone
- status[default]
- CONTACT FOR PUBLIC QUERIESDr. Syed Wasif Gillani
- CONTACT for SCIENTIFIC QUERIESDr. Syed Wasif Gillani
- Sponsor/Initiator Dr. Syed Wasif Gillani
- Funding
(Source(s) of Monetary or Material Support)
Dr. Syed Wasif Gillani
- PublicationsPending
- Brief summaryPending
- Main changes (audit trail)
- RECORD17-nov-2016 - 5-mrt-2017


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