EUCTR2015-001552-30-DK
Active, Not Recruiting
Phase 1
Effect of dapagliflozin, metformin and physical activity on glucose variability, body composition and cardiovascular risk in pre-diabetes (The PRE-D Trial) - A randomised, parallel, open-label, intervention study - Pre-D Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Steno Diabetes Center A/S
- Enrollment
- 160
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HbA1c 6\.0\-6\.4% (42\-47 mmol/mol)
- •Age 35\-70 years
- •BMI \= 25 kg/m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 60
Exclusion Criteria
- •Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression
- •Treatment with hormones which affect glucose metabolism
- •Treatment with loop diuretics or thiazolidinediones
- •Treatment with beta blockers or peroral steroids
- •Bariatric surgery within the past 2 years
- •Impaired renal function defined as an estimated GFR\<60 ml/min/1\.73m2
- •Neurogenic bladderdisorders
- •Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion
- •Pegnant or lactating women
- •Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implantation hormonal vaginal ring, transdermal application, or intra\-uterine devices
Outcomes
Primary Outcomes
Not specified
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