Clinical trial NCT02145442: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overweight
Obesity
Keywords: Impaired fasting glucose
Prediabetes
Obesity
Overweight
Insulin sensitivity
Weight loss
Nutritional supplement
Waist
Body composition
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the effect of Obex® on fasting glucose levels
timeFrame: Three months of treatment
measure: To determine the safety of serious supplement-related adverse events
timeFrame: Three months of treatment
Secondary outcomes:
measure: To evaluate the effect of Obex® on fasting insulin levels
timeFrame: Three months of treatment
measure: • 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)
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes
timeFrame: Three months of treatment
measure: • 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)
timeFrame: Three months of treatment
measure: • To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on the body weight.
timeFrame: Three months of treatment
measure: • To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on the waist and hip circumferences
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on arterial blood pressures (BP)
timeFrame: Three months of treatment
measure: • To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on creatinine and uric acid concentrations
timeFrame: Three months of treatment
measure: To evaluate the effect of Obex® on haemoglobin and serum iron levels
timeFrame: Three months of treatment
Other outcomes:
Locations:
city: Plaza de la Revolución
country: Cuba
facility: National Institute of Endocrinology
state: Havana
Study officials:
affiliation: National Institute of Endocrinology, Havana, Cuba
name: Eduardo Cabrera, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: