OverweightPhase 2/3NCT02145442
Effects of Obex in Overweight and Obese Patients
A Phase 2/3 study testing Obex in people with Overweight and Obesity, run by Catalysis SL at 1 site in Cuba.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Obex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCuba
- Study dates
- Jun 2014to Nov 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Overweight and Obese subjects with and without IFG
- Ability to provide informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Cuba1 site
National Institute of Endocrinology
Plaza de la Revolución, La Habana, 10400
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Obex
- Keywords
- Impaired fasting glucose, Prediabetes, Obesity, Overweight, Insulin sensitivity, Weight loss, Nutritional supplement, Waist, Body composition
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObexDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Obex | Experimental | Obex®, two oral sachets daily during three months. Receives: Dietary Supplement: Obex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months of treatment
To determine the safety of serious supplement-related adverse events
Adverse events will be evaluated during the three months of treatment
Measured: Three months of treatment
Secondary outcomes (13)
To evaluate the effect of Obex® on fasting insulin levels
The insulin levels will be evaluated at baseline and at the end of treatment.
Measured: 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)
The HOMA-IR will be evaluated at baseline and at the end of treatment.
Measured: 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
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])
Measured: 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)
The HOMA-B will be evaluated at baseline and at the end of treatment
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months 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.
Measured: Three months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Cabrera, M.D., Ph.D., Principal investigator, National Institute of Endocrinology, Havana, Cuba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145442
- Sponsor's protocol ID
- OBEX-IFG-2014
- Status last verified
- May 2018
- First submitted
- 20 May 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
- ClinicalTrials.gov ID
- NCT02145442
- Acronym / sponsor ID
- OBEX-IFG-2014
- Conditions
- Overweight, Obesity
- Keywords
- Impaired fasting glucose, Prediabetes, Obesity, Overweight, Insulin sensitivity, Weight loss, Nutritional supplement, Waist
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obex | Experimental | Dietary Supplement: ObexObex®, two oral sachets daily during three months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overweight and Obese subjects with and without IFG
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObexObex® 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. | Dietary supplement | Obex |
Primary outcome
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
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
13 secondary outcomes
To evaluate the effect of Obex® on fasting insulin levels
Time frame: 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
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
• 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
• To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)
Time frame: Three months of treatment
To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)
Time frame: Three months of treatment
To evaluate the effect of Obex® on the body weight.
Time frame: 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
To evaluate the effect of Obex® on the waist and hip circumferences
Time frame: Three months of treatment
To evaluate the effect of Obex® on arterial blood pressures (BP)
Time frame: 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
To evaluate the effect of Obex® on creatinine and uric acid concentrations
Time frame: Three months of treatment
To evaluate the effect of Obex® on haemoglobin and serum iron levels
Time frame: Three months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Cabrera, M.D., Ph.D. principal investigator
National Institute of Endocrinology, Havana, Cuba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Obex in people with Overweight and Obesity, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of Obex® on fasting glucose levels (time frame: Three months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.