E11.90
Conditions
Interventions
Group 1: Combined lifestyle intervention with low-calorie formula diet, nutritional advice, exercise program, continuous glucose monitoring
Sponsors
Klinikum der Universität München, Campus Innenstadt
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalized 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
| Measure | Time frame |
|---|---|
| patient acceptance of individual intervention components possible parameters for patient stratification physiologic changes occurring with diabetes remission | — |
Countries
Germany
Contacts
Public ContactAndreas Lechner
Klinikum der Universität München; Medizinische Klinik 4; Studienzentrum Diabetes
Outcome results
None listed