The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
66
The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
Medical University Graz
Graz, Austria
University Hospital Graz
Graz, Austria
Medical University Vienna
Vienna, Austria
University Hospital of Tübingen
Tübingen, Germany
University Hospital
Bern, Switzerland
To describe changes in hepatic fat content between groups.
Time frame: week 26, week 52
To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine.
Time frame: week 26, week 52
To evaluate changes in body fat and visceral adipose tissue between groups.
Time frame: week 26, week 52
To describe changes in waist and hip circumferences between groups.
Time frame: weel 26, week 52
To describe changes in eating behavior and food selection between groups.
Time frame: week 26, week 52
To describe changes in well being and disease perception between groups.
Time frame: week 26, week 52
To evaluate the daily insulin dose between groups.
Time frame: 1 year
To describe the fasting blood glucose between groups.
Time frame: 1 year
To evaluate hypoglycaemia between groups.
Time frame: 1 year
To evaluate safety between groups.
Time frame: 1 year
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