Insulin Resistance Clinical Trial
Official title:
Cytochrome P450 2E1 and Iron Overload
The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2006 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Male patients aged from 18 to 70 years - Hepatic iron overload measured by magnetic resonance imaging [MRI] (> 36 µmol/g and < 200 µmol/L) - Homozygosity for the C282Y mutation of the HFE or dysmetabolic iron overload syndrome (DIOS) based on the presence of at least one of these following metabolic abnormalities: - Overweight: BMI > 25 kg/m2 - Waist/hip circumference (cm) > 0.90 - Diabetes mellitus (fasting blood glucose level >1.25g/L or blood glucose level after 2 hours > 2g/L) or glucose intolerance (fasting blood glucose level between 1.10 and 1.25g/L) - Total cholesterolemia > 6.2 mmol/L or HDL-Cholesterol < 0.9 mmol/L - TG>= 1.7 mmol - Written informed consent Non-Inclusion Criteria: - Consumption of alcohol > 50 g/day and of any CYP2E1 inhibitor substances - Smoker > 5 cigarets/day - History of blood donation or venesection - Other causes of iron overload: aceruloplasminaemia, haematological disorder (abnormal blood counting), late cutaneous porphyria (cutaneous bullous disorders and photosensibilisation) , martial treatment, repeated transfusions. - Inflammatory syndrome (CRP > 3ng/ml) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Nantes | Nantes | |
France | Unité d'Investigation Clinique - Hôpital Pontchaillou | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | variation of chlorzoxazone metabolization rate measured before and after venesection | Baseline and after iron desaturation completion | No | |
Secondary | variation of blood Malonedialdehyde rate | Baseline and after iron desaturation completion | No | |
Secondary | variation of blood 4-hydroxynonenal rate | Baseline and after iron desaturation completion | No | |
Secondary | variation of blood Glutathion rate | Baseline and after iron desaturation completion | No | |
Secondary | variation of serum Vitamin E rate | Baseline and after iron desaturation completion | No | |
Secondary | Variation of serum Vitamin C rate | Baseline and after iron desaturation completion | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03383822 -
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT04203238 -
Potato Research for Enhancing Metabolic Outcomes
|
N/A | |
Recruiting |
NCT03658564 -
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance
|
N/A | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03627104 -
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
|
N/A | |
Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A | |
Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
Completed |
NCT03809182 -
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
|
Phase 4 | |
Completed |
NCT01809288 -
Identifying Risk for Diabetes and Heart Disease in Women
|
||
Completed |
NCT04642482 -
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
|
Phase 4 | |
Terminated |
NCT03278236 -
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
Withdrawn |
NCT04741204 -
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
|
Phase 4 | |
Not yet recruiting |
NCT05540249 -
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
|
N/A |