Insulin Resistance Clinical Trial
— SAINPOSOfficial title:
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.
Status | Completed |
Enrollment | 13 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age between 18 and 70 years - Ferritin between 450 and 1000 µg/L - Hepatic iron overload proved by MRI (CHF >36 µmol/g) - Body mass index > 25 kg/m² - Fasting glycemia <1,26 g/L - HbA1c < 6,5% - Signed written and informed consent Exclusion Criteria: - Other causes of hyperferritinemia: - Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant diseases - Hyperferritinemia-cataract syndrome (familial cataract or personal history of cataract before 50 years old) - Low ceruloplasmin level - Porphyria (cutaneous signs) - Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D coumpound heterozygous genotypes) - Contraindication of phlebotomy - Haemoglobin <13,5 g/dL (threshold established by the Etablissement Français du Sang) - Heart failure or coronary heart diseases - Hepatic failure, renal (GFR <50mL/min) or respiratory insufficiency (chronic dyspnea) - Poor venous system - Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease - Alcohol consumption more than 21 doses per week during 5 years or more - Type 1 or type 2 diabetes - Oral anti-diabetic, corticoids or immune suppressor drugs - Hepatic severe disease - Claustrophobia, having a pace-maker or intracerebral clips - Subjects deprived of their liberty by judicial or administrative decision, subjects that are not affiliated to social security or topics exclusion period of a previous study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU | Nantes | |
France | CHU | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose Infusion Rate by euglycemic-hyperinsulinic clamp | 6 months | No | |
Secondary | hepatic parameters | 6 months | No | |
Secondary | inflammation markers | IL-6, TNF alpha, CRP | 6 months | No |
Secondary | Adipokins markers | adiponectin, PAI1, leptin | 6 months | No |
Secondary | SHBG | 6 months | No | |
Secondary | HOMA-IR | 6 months | No | |
Secondary | Hepatic iron overload (MRI) | transaminase (ALT, AST), gamma GT | 6 months | No |
Secondary | Abdominal and sub-cutaneous fat surface (MRI) | 6 months | No | |
Secondary | iron parameters | serum iron, ferritin, saturation of transferrin | at 6 months | No |
Secondary | lipid profile | HDL-c, LDL-c, triglycerides | at 6 months | 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 | |
Not yet recruiting |
NCT05540249 -
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
|
N/A | |
Withdrawn |
NCT04741204 -
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
|
Phase 4 |