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| Name | Class |
|---|---|
| Medical University Vienna | UNKNOWN |
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The goal of this clinical trial is to detect the impact of the 3-month complex lifestyle intervention, consisting of dietary counselling, supervised exercise training and cognitive-behavioural intervention in middle-aged sedentary individuals with obesity, specific questions are:
Researchers will examine effects of exercise training intervention on whole body energy metabolism, by integrating clinical, biochemical and molecular data.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supervised lifestyle modification | Behavioral | Supervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly). |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic flexibility in response to submaximal exercise and nutritional challenge | Metabolic flexibility (metabolic substrate switching) will be measured using indirect calorimetry during submaximal exercise test (on stationary bike) and in response to nutritional challenge (fasting / glucose uptake during oGTT) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| cardiopulmonary fitness (VO2max) | Cardiopulmonary fitness will be measured by bicycle spiro-ergometry | 24 months |
| Index of insulin resistance (oGTT) | Index of insulin resistance will be calculated from the results of the frequently sampled oral glucose tolerance test oGTT. |
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Inclusion Criteria: BMI 30-45 kg.m-2 -
Exclusion Criteria: smoking, cancer,
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Ukropcová, Prof. MD PhD | Biomedical Research Center Slovak Acad Sci | Study Chair |
| Jozef Ukropec, PhD, DSc | Biomedical Research Center Slovak Acad Sci | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Obesity Management EASO, Biomedical Research Center SAS | Bratislava | Bratislava Region | 84505 | Slovakia |
Study protocol and SAP will be available upon study completion, and primary and secondary outcomes (clinical study report) will be shared after publishing the results in a scientific journal.
06/2026 (start date) indefinitely (end date)
researchers with legitimate interest
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 24 months |
| abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral) | abdominal adiposity will be assessed by quadrupedal biopimpedance, and adipose tissue distribution by magnetic resonance imagining | 24 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |