Therapy of Obesity and Diabetes Mellitus Type 2

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2

Conditions
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Obesity, Diabetes Type 2, Weight Loss

Intervention / Treatment
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* Other: Structured weight-loss program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: known type 2 diabetes body-mass-index between 27 and 45 kg/m² Exclusion Criteria: treatment with incretin mimetic drugs < 3 month pregnancy immobilization severe heart, liver or renal failure dementia eating disorder alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks | Other: Structured weight-loss program<br>* 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.<br>* Other names: OPTIFAST II Short Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c value |  | measured at week 0 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | measured at week 0, 6 and 15 | 
| Change in body-mass-index |  | measured at week 0, 6 and 15 | 
| Change in waist circumference |  | measured at week 0, 6 and 15 | 
| Change in hip circumference |  | measured at week 0, 6 and 15 | 
| Change in body composition | Body composition will be assessed with bioimpedance | 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 | measured at week 0, 6 and 15 | 
| Change in visceral fat volume | Visceral fat volume will be assessed with magnet resonance imaging | measured at week 0, 6 and 15 | 
| Change in fasting glucose |  | measured at week 0 and 15 | 
| Change in fasting insulin |  | measured at week 0 and 15 | 
| Change in triglycerides |  | measured at week 0, 6 and 15 | 
| Change in cholesterol |  | measured at week 0, 6 and 15 | 
| Change in HDL cholesterol |  | measured at week 0, 6 and 15 | 
| Change in LDL cholesterol |  | measured at week 0, 6 and 15 | 
| Change in alanine transaminase |  | measured at week 0, 6 and 15 | 
| Change in aspartate transaminase |  | measured at week 0, 6 and 15 | 
| Change in gamma-glutamyl transferase |  | measured at week 0, 6 and 15 | 
| Change in alkaline phosphatase |  | measured at week 0, 6 and 15 | 
| Change in uric acid |  | measured at week 0, 6 and 15 | 
| Change in 25-hydroxy-vitamine d3 |  | measured at week 0 and 15 | 
| Change in 1,25-dihydroxy-vitamine d3 |  | measured at week 0 and 15 | 
| Change in plasma calcium |  | measured at week 0 and 15 | 
| Change in plasma phosphate |  | measured at week 0 and 15 | 
| Change in insulin-like growth factor-1 |  | measured at week 0 and 15 | 
| Change in testosterone |  | measured at week 0 and 15 | 
| Change in sex hormone-binding globulin |  | measured at week 0 and 15 | 
| Change in quality of life | Quality of life was determined using SF-12 | measured at week 0 and 15 | 
| Change in sleep quality | Sleep quality was determined using the Pittsburgh sleep quality index | 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 | measured at week 0 and 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Formula diet