Effects of glucose-lowering interventions in pre-diabetes

Phase 1

• Conditions: Pre-diabetes; MedDRA version: 18.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2015-001552-30-DK
• Lead Sponsor: Steno Diabetes Center A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

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

•Allergic to one or more of the medications used in the study

•Treatment with peroral steroids

•Concomitant participation in other intervention study

•Unable to understand the informed consent and the study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified