Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2014-06-30
2014-11-30
Brief Summary
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* Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
* An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients
* Important adverse events have been reported with the use of antiobesity drugs.
* The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT.
* Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.
* Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Obex
Obex®, two oral sachets daily during three months.
Obex
Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity.
Interventions
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Obex
Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
Exclusion Criteria
* Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
* Sepsis or any other condition that could potentially interfere with treatment
* History of bariatric surgery
* Pregnancy or lactation
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Anyone with chronic medical conditions requiring regular intake of any prescription medications.
* Used drugs for weight loss (e.g., Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Accomplia \[rimonabant\], Alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
* Are actively participating in, or have participated in a formal weight loss program within the last 3 months
20 Years
60 Years
ALL
No
Sponsors
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Catalysis SL
INDUSTRY
Responsible Party
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Principal Investigators
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Eduardo Cabrera, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Endocrinology, Havana, Cuba
Locations
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National Institute of Endocrinology
Plaza de la Revolución, La Habana, Cuba
Countries
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Other Identifiers
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OBEX-IFG-2014
Identifier Type: -
Identifier Source: org_study_id
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