To evaluate a standardized weight-loss program as treatment option for obesity and type 2 diabetes, changes in body composition and metabolic control are investigated in obese patients with diabetes.
Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized weight-loss program (six weeks of formula diet, followed by the reintroduction of regular food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All subjects undergo bioelectrical impedance analyses to investigate body composition and magnet resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time points: first before the program, then at the end of the six weeks of formula diet and finally, at the end of the program after 15 weeks. Laboratory data are measured before and after the program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
During the fasting phase, daily consumption consists of five sachets fully replacing normal food and corresponded to an energy content of 800 kcal. This fasting phase is followed by a four-week refeeding phase, during which regular food will be reintroduced and formula diet is gradually replaced until a daily total intake of 1200 kcal is reached. During the last five weeks of the program, energy intake is gradually increased to an individual level between 1200 kcal and 1500 kcal that allowed subjects to keep their weight stable. Once a week participants visit the study center to monitor health status and taking part in supervised exercises and a nutritional and behavioral counseling.
University Medicine Greifswald
Greifswald, Germany
Change in HbA1c value
Time frame: measured at week 0 and 15
Change in weight
Time frame: measured at week 0, 6 and 15
Change in body-mass-index
Time frame: measured at week 0, 6 and 15
Change in waist circumference
Time frame: measured at week 0, 6 and 15
Change in hip circumference
Time frame: measured at week 0, 6 and 15
Change in body composition
Body composition will be assessed with bioimpedance
Time frame: measured at week 0, 6 and 15
Change in fat fractions of abdominal organs
Fat fraction of abdominal organs will be assessed with magnet resonance imaging
Time frame: measured at week 0, 6 and 15
Change in visceral fat volume
Visceral fat volume will be assessed with magnet resonance imaging
Time frame: measured at week 0, 6 and 15
Change in fasting glucose
Time frame: measured at week 0 and 15
Change in fasting insulin
Time frame: measured at week 0 and 15
Change in triglycerides
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Time frame: measured at week 0, 6 and 15
Change in cholesterol
Time frame: measured at week 0, 6 and 15
Change in HDL cholesterol
Time frame: measured at week 0, 6 and 15
Change in LDL cholesterol
Time frame: measured at week 0, 6 and 15
Change in alanine transaminase
Time frame: measured at week 0, 6 and 15
Change in aspartate transaminase
Time frame: measured at week 0, 6 and 15
Change in gamma-glutamyl transferase
Time frame: measured at week 0, 6 and 15
Change in alkaline phosphatase
Time frame: measured at week 0, 6 and 15
Change in uric acid
Time frame: measured at week 0, 6 and 15
Change in 25-hydroxy-vitamine d3
Time frame: measured at week 0 and 15
Change in 1,25-dihydroxy-vitamine d3
Time frame: measured at week 0 and 15
Change in plasma calcium
Time frame: measured at week 0 and 15
Change in plasma phosphate
Time frame: measured at week 0 and 15
Change in insulin-like growth factor-1
Time frame: measured at week 0 and 15
Change in testosterone
Time frame: measured at week 0 and 15
Change in sex hormone-binding globulin
Time frame: measured at week 0 and 15
Change in quality of life
Quality of life was determined using SF-12
Time frame: measured at week 0 and 15
Change in sleep quality
Sleep quality was determined using the Pittsburgh sleep quality index
Time frame: measured at week 0 and 15
Change in diet history
7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake
Time frame: measured at week 0 and 15