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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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

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
Intervention / Treatment
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

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

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

Catalysis SL

Investigators

  • 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

June 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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