Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

October 25, 2011 updated by: Hospital de Clinicas de Porto Alegre

ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL

The aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0% and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. It is an open label, observational study, with a duration of 4-6 years. Patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. They will be followed on a monthly basis by a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type 2 diabetic patients attending a primary care outpatient facility

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

  • Terminal disease (renal, cancer, heart failure)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment
124 patients attending the primary care unit included after formal consent.
Drug: Metformin
850 mg TID
Other Names:
  • Initial drug added to non-pharmacological measures
Drug: Glybenclamide
10 mg BID
Other Names:
  • Second oral agent to be added
Drug: NPH insulin
Variable SC dose
Other Names:
  • Insulin added to or substituted for OA
Drug: Hydrochlorothiazide
25 mg QD introduced as initial therapy for hypertension
Other Names:
  • Inital RX for hypertension
Drug: Propranolol
40 mg BID
Other Names:
  • Introduced if diuretic + captopril do not control BP
Drug: Captopril
50 mg TID
Other Names:
  • Added to hydrochlorothiazide if BP not attained
Drug: Amlodipine
10 mg QD
Other Names:
  • Added to previous if BP control BP not satisfactory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycated hemoglobin A1c
Time Frame: 3 months
3 months
Blood pressure
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
24 hr blood glucose profile
Time Frame: once
once
Fasting blood glucose
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Rogerio Friedman, MD, PhD, Hospital de Clinicas de Porto Alegre
  • Study Chair: Jorge L Gross, MD, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe