Status:
COMPLETED
MR Fat Quantification and Elastography During a Very Low-calorie-ketogenic Diet (Pronokal Method®) vs a Low Calorie Diet
Lead Sponsor:
Protein Supplies SL
Conditions:
Liver Fat
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multicenter, open-label, randomized and controlled study of the effects of weight loss and reduced visceral fat on non-alcoholic fat infiltration into liver after a very low calorie ketog...
Detailed Description
The investigators will include obese patients with BMI higher than 30 kg / m2 to follow a standardized multidisciplinary weight-loss program (PronoKal® Method), which consists of a very-low-calorie di...
Eligibility Criteria
Inclusion
- Patients of either sex, older than 18 years
- Obese patients with BMI equal or over 30kg/m2
- Patients who agree to participate and sign the Informed Consent
Exclusion
- Pregnant or lactating women.
- Patients weighing over 140 kg (by limitation of the MRI device)
- Patients on anti-obesity drugs (eg, sibutramine, orlistat and liraglutide) or weight-interfering medications (eg, topiramate). In such cases a wash out period of 3 months is required.
- Patients with alcohol intake \> 20 g/day in women and \> 30 g/day in men.
- Patients with liver failure or with pathologies that may affect the liver
- Patients with other causes of liver steatosis: chronic viral hepatitis and/or drug intake (corticosteroids, estrogens, NSAIDs, calcium antagonists, amiodarone, tamoxifen, tetracyclines, chloroquine, antiretrovirals, perhexiline).
- Patients with eating disorders.
- Patients with any psychiatric disorder (eg schizophrenia, bipolar disorder, substance abuse, severe depression).
- Patients receiving dicumarinic anticoagulants (Sintrom®).
- Patients taking corticosteroids.
- Patients with severe kidney failure (gfr \<30).
- Patients with type 1 and type 2 diabetes mellitus.
- Patients with hemopathies, including coagulation disorders
- Patients with cardiovascular or cerebrovascular disease (of heart rate disorders, recent infarction \[\<6m\], unstable angina, decompensated heart failure, recent stroke \[\<6m\]).
- Patients in acute attack of gout.
- Patients with renal lithiasis verified by ultrasound.
- Patients with cholelithiasis verified by ultrasound.
- Patients with electrolyte imbalance, according to medical criteria.
- Patients with orthostatic hypotension.
- Patients with cancer or history of cancer who have not been discharged from oncology
- Patients who are not expected to attend follow-up visits
Key Trial Info
Start Date :
September 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04322110
Start Date
September 12 2016
End Date
October 25 2017
Last Update
March 26 2020
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