Pilot study for individualized remission induction of type 2 diabetes
- Conditions
- E11.90
- Registration Number
- DRKS00020453
- Lead Sponsor
- Klinikum der Universität München, Campus Innenstadt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
T2D diagnosed within the last 6 years. T2D diagnosis confirmed by at least two different tests [HbA1c = 6.5% and (fasting glucose = 126 mg/dl or random glucose = 200 mg/dl or 2-h glucose in an oral glucose tolerance test = 200 mg/dl)]
Diabetic continuous glucose profile at study inclusion (at least two timepoints with fasting sensor glucose = 126 mg/dl or any sensor glucose value = 200 mg/dl; interruption of the antidiabetic medication, if necessary, for 1-7 days)
Written informed consent
Other diabetes type than type 2
Pregnancy or planned pregnancy in the following 12 months
Planned surgery in the following 12 months
eGFR < 30 ml/min/1.73 m²
Myocardial infarction or stroke within the last 6 months
Malignancy
Heart failure = NYHA 2
Previous or planned bariatric surgery
Psychiatric disorder requiring inpatient treatment within the last 12 months
Alcohol abuse or use of illegal drugs
Other disease that prevents participation in the planned lifestyle intervention
Participation in another clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ormalized continuous glucose profile without antidiabetic medication after an intervention period of 1-6 months, defined as at least 5 consecutive days with 96 percent of the time spent with sensor glucose values between 70 and 140 mg/dl. If no sensor data is available, HbA1c < 5.7% plus fasting blood glucose less than 100 mg/dl on 5 consecutive days will serve as an alternative endpoint.
- Secondary Outcome Measures
Name Time Method patient acceptance of individual intervention components<br>possible parameters for patient stratification<br>physiologic changes occurring with diabetes remission