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NCT Number: NCT01099306

Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

This study devised an experimental focused pharmaceutical care program, allowed a clinical pharmacist to work in a physician office to assess and manage patients' metabolic syndrome status and its individual components. This study described the clinical benefits of physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and blood pressure measurements, involving medication, diet, physical activity and patient heath care counseling.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

32 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

family medicine clinic JUH

Amman, Amman Governorate, 13046, Jordan

About this study

A single blinded prospective randomized controlled trial conducted in family medicine outpatients clinics in Jordan. The study enrolled 199 patients met the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) criteria for the diagnosis of MS upon the time of enrollment. Patients were randomized into: 110 participants into the intervention arm (pharmacist-physician collaborative approach) and 89 into the control arm (physician only team). Only patients in the intervention arm were provided pharmacist recommendations and pharmaceutical care counseling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meeting at least 3 of the 5 criteria for the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) for the diagnosis of Metabolic syndrome upon the time of enrollment. :
  • Abdominal circumference >102 cm in males or >88 cm in females.
  • HDL cholesterol < 40 mg/dl for males or < 50 mg/dl for females.
  • Triglycerides ≥ 150 mg/dl.
  • Blood pressure ≥ 130/85 mmHg or receiving hypertension treatment.
  • Baseline glycemia ≥ 110 mg/dl.

Exclusion criteria

  • Patients with hypertensive urgency or emergency with BP more than (180/110).
  • Patients with recent stroke or myocardial infraction (within past 6 months).
  • Patients with Class III or IV Chronic heart Failure (CHF).
  • Patients with Unstable angina.
  • Patients with Serious renal or hepatic disease.
  • Pregnant patients.
  • Patients with Dementia or cognitive impairment.
  • If the patient is unable to provide informed written consent.

Treatment and study plan

pharmaceutical care services

Other

Patients' metabolic components were assessed and managed collaboratively by focused care plan designed by the clinical pharmacist and approved by the physician.Pharmacist emphasized the change in lifestyle, particularly weight loss and physical activity as a first line therapy for at least 3 months, patients were started on drug therapy when needed as recommended by clinical guidelines.

Primary outcomes

  1. Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.

    Time frame: 6 monthS

    Primary outcomes were specified as:

    • Fasting blood glucose < 110 mg/dl.
    • Body weight BMI < 25 kg/m2.
    • Waist circumference ≤ 102 cm (40 in) in men and ≤ 88 cm (35 inches) in women.
    • Serum triglycerides < 150 mg/dl.
    • HDL cholesterol ≥40mg/dl in men and ≥50mg/dl in women.
    • Blood pressure < 130/85 mm Hg or < 130/80 mm Hg when patients were diabetic.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 6, 2010
Registry last updated
Apr 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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