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Clinical Trials/ACTRN12620001129976
ACTRN12620001129976
Recruiting
未知

Efficacy of a Structured Weight Management Program for achieving Diabetes REmission in a primary care setting in Australia – Diabetes Remission Clinical Trial-Australia(DiRECT-Aus Study)

Diabetes NSW & ACT0 sites250 target enrollmentOctober 30, 2020
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Diabetes NSW & ACT
Enrollment
250
Status
Recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 30, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Diabetes NSW & ACT

Eligibility Criteria

Inclusion Criteria

  • •Men and women aged 20\-65 years, all ethnicities
  • •T2DM of duration 0\-6 years
  • •Body mass index (BMI)\>27 kg/m2

Exclusion Criteria

  • •Current insulin use
  • •HbA1c greater than 86 mmol/mol (10%) at screening
  • •Weight loss of greater than 5kg within the last 6 months
  • •Recent eGFR equals 45 ml/min/1\.732
  • •Substance abuse
  • •Known cancer
  • •Myocardial infarction within previous 6 months
  • •Severe or unstable Heart Failure defined as equivalent to the New York Heart Association (NYHA):
  • •A.Grade 3 \- marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or breathlessness, and
  • •B.Grade 4 \- unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

Outcomes

Primary Outcomes

Not specified

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