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Effects of Obex in Overweight and Obese Patients

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Obex
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Impaired fasting glucose, Prediabetes, Obesity, Overweight, Insulin sensitivity, Weight loss, Nutritional supplement, Waist, Body composition

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Endocrinology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obex

Arm Description

Obex®, two oral sachets daily during three months.

Outcomes

Primary Outcome Measures

To evaluate the effect of Obex® on fasting glucose levels
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels
To determine the safety of serious supplement-related adverse events
Adverse events will be evaluated during the three months of treatment

Secondary Outcome Measures

To evaluate the effect of Obex® on fasting insulin levels
The insulin levels will be evaluated at baseline and at the end 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)
The HOMA-IR will be evaluated at baseline and at the end of treatment.
To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes
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])
• 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)
The HOMA-B will be evaluated at baseline and at the end of treatment
• To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)
The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment.
To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)
The HbA1c will be evaluated at baseline and at the end of treatment.
To evaluate the effect of Obex® on the body weight.
The body weight will be measured at baseline and at the end of treatment.
• To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)
The BMI and CI will be measured at baseline and at the end of treatment.
To evaluate the effect of Obex® on the waist and hip circumferences
Waist and Hip circumferences will be measured at baseline and at the end of treatment.
To evaluate the effect of Obex® on arterial blood pressures (BP)
The arterial BP will be evaluated at baseline and at the end of treatment.
• To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)
The hepatic enzymes will be evaluated at baseline and at the end of treatment.
To evaluate the effect of Obex® on creatinine and uric acid concentrations
The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment.
To evaluate the effect of Obex® on haemoglobin and serum iron levels
The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment.

Full Information

First Posted
May 20, 2014
Last Updated
May 3, 2018
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT02145442
Brief Title
Effects of Obex in Overweight and Obese Patients
Official Title
Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Impaired fasting glucose, Prediabetes, Obesity, Overweight, Insulin sensitivity, Weight loss, Nutritional supplement, Waist, Body composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obex
Arm Type
Experimental
Arm Description
Obex®, two oral sachets daily during three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Obex
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the effect of Obex® on fasting glucose levels
Description
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels
Time Frame
Three months of treatment
Title
To determine the safety of serious supplement-related adverse events
Description
Adverse events will be evaluated during the three months of treatment
Time Frame
Three months of treatment
Secondary Outcome Measure Information:
Title
To evaluate the effect of Obex® on fasting insulin levels
Description
The insulin levels will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
• 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)
Description
The HOMA-IR will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes
Description
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])
Time Frame
Three months of treatment
Title
• 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)
Description
The HOMA-B will be evaluated at baseline and at the end of treatment
Time Frame
Three months of treatment
Title
• To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)
Description
The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)
Description
The HbA1c will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on the body weight.
Description
The body weight will be measured at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
• To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)
Description
The BMI and CI will be measured at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on the waist and hip circumferences
Description
Waist and Hip circumferences will be measured at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on arterial blood pressures (BP)
Description
The arterial BP will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
• To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)
Description
The hepatic enzymes will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on creatinine and uric acid concentrations
Description
The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment
Title
To evaluate the effect of Obex® on haemoglobin and serum iron levels
Description
The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment.
Time Frame
Three months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Cabrera, M.D., Ph.D.
Organizational Affiliation
National Institute of Endocrinology, Havana, Cuba
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Endocrinology
City
Plaza de la Revolución
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba

12. IPD Sharing Statement

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