Effects of Obex in Overweight and Obese Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02145442
• Date of registration: 20/05/2014
• Prospective Registration: Yes
• Primary sponsor: Catalysis SL
• Public title: Effects of Obex in Overweight and Obese Patients
• Scientific title: Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
• Date of first enrolment: June 2014
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02145442
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Cuba

Contacts

• Name: Eduardo Cabrera, M.D., Ph.D.
• Affiliation: National Institute of Endocrinology, Havana, Cuba

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overweight

Obesity

Intervention(s)

Dietary Supplement: Obex

Primary Outcome(s)

To evaluate the effect of Obex® on fasting glucose levels [Time Frame: Three months of treatment]

To determine the safety of serious supplement-related adverse events [Time Frame: Three months of treatment]

Secondary Outcome(s)

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 arterial blood pressures (BP) [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 the waist and hip circumferences [Time Frame: Three months of treatment]

To evaluate the effect of Obex® on fasting insulin levels [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 cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c) [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 ß-cell function by homeostatic model assessment-beta cell (HOMA-ß), 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 Body Mass Index (BMI) and Conicity Index (CI) [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 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 haemoglobin and serum iron levels [Time Frame: Three months of treatment]

Secondary ID(s)

OBEX-IFG-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors