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Status unknownNCT00935805Updated Oct 26, 2011

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

An observational study in Diabetes Mellitus and Arterial Hypertension, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-10-26.

Sponsored by Hospital de Clinicas de Porto Alegre · Observational

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
124
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus
  • Arterial Hypertension

Keywords

  • Diabetes Mellitus
  • Arterial Hypertension
  • Treatment
  • Primary Care
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's planned enrollment of 124 is below the median of 210 across 1,358 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Type 2 diabetic patients attending a primary care outpatient facility

Inclusion criteria

  • Type 2 diabetes mellitus (WHO)

Exclusion criteria

Exclusion Criteria:

  • Terminal disease (renal, cancer, heart failure)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
124 participants (estimated)

Groups and cohorts

  • Treatment

    124 patients attending the primary care unit included after formal consent.

    Drug: Metformin · Drug: Glybenclamide · Drug: NPH insulin · Drug: Hydrochlorothiazide · Drug: Propranolol · Drug: Captopril · Drug: Amlodipine

Interventions

  • DrugMetformin

    850 mg TID

    Also known as: Initial drug added to non-pharmacological measures

  • DrugGlybenclamide

    10 mg BID

    Also known as: Second oral agent to be added

  • DrugNPH insulin

    Variable SC dose

    Also known as: Insulin added to or substituted for OA

  • DrugHydrochlorothiazide

    25 mg QD introduced as initial therapy for hypertension

    Also known as: Inital RX for hypertension

  • DrugPropranolol

    40 mg BID

    Also known as: Introduced if diuretic + captopril do not control BP

  • DrugCaptopril

    50 mg TID

    Also known as: Added to hydrochlorothiazide if BP not attained

  • DrugAmlodipine

    10 mg QD

    Also known as: Added to previous if BP control BP not satisfactory

06

What researchers measure

Primary outcomes

  1. Glycated hemoglobin A1c

    Time frame: 3 months

  2. Blood pressure

    Time frame: 1 month

Secondary outcomes

  1. 24 hr blood glucose profile

    Time frame: once

  2. Fasting blood glucose

    Time frame: 3 months

07

Study locations

1 site
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, RS 90035-903, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00935805
Lead sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Responsible party
Sponsor
First posted
Jul 9, 2009
Start date
Jul 2006
Primary completion
Jan 2012 (estimated)
Completion
Jul 2012 (estimated)
Last update
Oct 26, 2011

Study contacts

Rogerio Friedman, MD, PhD
principal investigator · Hospital de Clinicas de Porto Alegre
Jorge L Gross, MD, PhD
study chair · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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