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

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ClinicalTrials.gov Identifier: NCT00935805
Recruitment Status : Unknown
Verified July 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2009
Last Update Posted : October 26, 2011
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Arterial Hypertension Drug: Metformin Drug: Glybenclamide Drug: NPH insulin Drug: Hydrochlorothiazide Drug: Propranolol Drug: Captopril Drug: Amlodipine

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Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : July 2006
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment
124 patients attending the primary care unit included after formal consent.
Drug: Metformin
850 mg TID
Other Name: Initial drug added to non-pharmacological measures

Drug: Glybenclamide
10 mg BID
Other Name: Second oral agent to be added

Drug: NPH insulin
Variable SC dose
Other Name: Insulin added to or substituted for OA

Drug: Hydrochlorothiazide
25 mg QD introduced as initial therapy for hypertension
Other Name: Inital RX for hypertension

Drug: Propranolol
40 mg BID
Other Name: Introduced if diuretic + captopril do not control BP

Drug: Captopril
50 mg TID
Other Name: Added to hydrochlorothiazide if BP not attained

Drug: Amlodipine
10 mg QD
Other Name: Added to previous if BP control BP not satisfactory




Primary Outcome Measures :
  1. Glycated hemoglobin A1c [ Time Frame: 3 months ]
  2. Blood pressure [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 24 hr blood glucose profile [ Time Frame: once ]
  2. Fasting blood glucose [ Time Frame: 3 months ]


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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetic patients attending a primary care outpatient facility
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

  • Terminal disease (renal, cancer, heart failure)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935805


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Investigators
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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

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00935805     History of Changes
Other Study ID Numbers: 06260
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: July 2011

Keywords provided by Hospital de Clinicas de Porto Alegre:
Diabetes Mellitus
Arterial Hypertension
Treatment
Primary Care

Additional relevant MeSH terms:
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Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Glyburide
Amlodipine
Hydrochlorothiazide
Propranolol
Captopril
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists