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Effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Carb dietary Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Carb diet | Other | Low Carb diet (max. 130g carbohydrates/d) for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test. | Change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry | Change from baseline to 6 months | |
| Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples |
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Inclusion Criteria:
Group A: HEALTHY LEAN CONTROLS
Group B: PRE-DIABETIC or DIABETIC OBESE
Exclusion Criteria:
Group A: HEALTHY LEAN CONTROLS
Group B: PRE-DIABETIC or DIABETIC OBESE
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Wölnerhanssen, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Clara Research Ltd, St Claraspital Basel | Basel | 4002 | Switzerland |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
| Change from baseline to 6 months |
| Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples | Human gut microbiota composition measured with metagenomic shotgun sequencing | Change from baseline to 6 months |
| Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI | Change from baseline to 6 months |
| Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI | Change from baseline to 6 months |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |