Last updated: October 20, 2021
Sponsor: Catalysis SL
Overall Status: Completed
Phase
3
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
N/AClinical Study ID
NCT03541005
OBEX-CAT-2018
Ages 20-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 andless than 40).
- Age between 20 and 65 years old.
- Values of fasting glucose < 7.0 mmol / L and at two hours < 11.1 mmol / L duringGlucose Tolerance Test (OGTT).
- Written informed consent of participation in the study.
Exclusion
Exclusion Criteria:
- Thyroid dysfunction (hypo or hyperthyroidism).
- Type 1 or type 2 diabetes.
- Prediabetes treated with oral agents.
- Alterations of lipids treated with drugs.
- Medicine consumption of or dietary supplements that influence the reduction of bodyweight.
- Consumption of steroids or prolonged use of them (last 3 months).
- Treatment with immunosuppressive drugs.
- Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis orsome type of malignancy condition) or acute at the time of inclusion.
- Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism,polycystic ovarian syndrome or hyperprolactinemia.
- History of symptomatic hypoglycaemia.
- History of chronic debilitating diseases, anemia and collagen diseases.
- History or existence psychological illness with eating disorders or toxicity.
- History of alcoholism or drug dependence.
- Inability to comply with the instructions of the investigation.
- Severe infections at the time of inclusion.
- Women of childbearing age who use hormonal contraceptives (oral or injectable).
- Pregnant or breastfeeding.
- Known sensitivity to any of the components of the formulation
- Gynoid fat distribution.
Study Design
Total Participants: 160
Study Start date:
October 01, 2018
Estimated Completion Date:
July 03, 2021
Connect with a study center
National Institute of Endocrinology
Havana, La Habana 10400
CubaSite Not Available
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