Effects of Obex in Overweight and Obese Patients

May 3, 2018 updated by: Catalysis SL

Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose

  • Obesity is an important and growing public health worldwide
  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Plaza de la Revolución, Havana, Cuba, 10400
        • National Institute of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight and Obese subjects with and without IFG
  • Ability to provide informed consent

Exclusion Criteria:

  • Presence of diabetes mellitus, hepatic, renal or cardiovascular disease
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Obex
Obex®, two oral sachets daily during three months.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the effect of Obex® on fasting glucose levels
Time Frame: Three months of treatment
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels
Three months of treatment
To determine the safety of serious supplement-related adverse events
Time Frame: Three months of treatment
Adverse events will be evaluated during the three months of treatment
Three months of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the effect of Obex® on fasting insulin levels
Time Frame: Three months of treatment
The insulin levels will be evaluated at baseline and at the end of treatment.
Three months of treatment
• To evaluate the effect of Obex® on insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5)
Time Frame: Three months of treatment
The HOMA-IR will be evaluated at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes
Time Frame: Three months of treatment

The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated at baseline and at the end of treatment.

QUICKI = [1/[log I0 + log G0], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = [40/I0])
Three months of treatment
• To evaluate the effect of Obex® on β-cell function by homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5)
Time Frame: Three months of treatment
The HOMA-B will be evaluated at baseline and at the end of treatment
Three months of treatment
• To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)
Time Frame: Three months of treatment
The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)
Time Frame: Three months of treatment
The HbA1c will be evaluated at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on the body weight.
Time Frame: Three months of treatment
The body weight will be measured at baseline and at the end of treatment.
Three months of treatment
• To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)
Time Frame: Three months of treatment
The BMI and CI will be measured at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on the waist and hip circumferences
Time Frame: Three months of treatment
Waist and Hip circumferences will be measured at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on arterial blood pressures (BP)
Time Frame: Three months of treatment
The arterial BP will be evaluated at baseline and at the end of treatment.
Three months of treatment
• To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)
Time Frame: Three months of treatment
The hepatic enzymes will be evaluated at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on creatinine and uric acid concentrations
Time Frame: Three months of treatment
The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment.
Three months of treatment
To evaluate the effect of Obex® on haemoglobin and serum iron levels
Time Frame: Three months of treatment
The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment.
Three months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catalysis SL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eduardo Cabrera, M.D., Ph.D., National Institute of Endocrinology, Havana, Cuba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OBEX-IFG-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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