Effects of Obex in Overweight and Obese Patients

NCT02145442 | Completed Phase 2 DMC

• 1 other identifier: OBEX-IFG-2014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Impaired fasting glucose; Prediabetes; Obesity; Overweight; Insulin sensitivity; Weight loss; Nutritional supplement; Waist; Body composition

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Three months of treatment

Secondary Outcomes (13)

• To evaluate the effect of Obex® on fasting insulin levels

  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)

  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

  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)

  Three months of treatment

• • To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)

  Three months of treatment

Study Arms (1)

Obex

EXPERIMENTAL

Obex®, two oral sachets daily during three months.

Dietary Supplement: Obex

Interventions

Obex DIETARY_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.

Obex

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight and Obese subjects with and without IFG
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

National Institute of Endocrinology

Plaza de la Revolución, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Insulin Resistance; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Body Weight Changes

Study Officials

• Eduardo Cabrera, M.D., Ph.D.

  National Institute of Endocrinology, Havana, Cuba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

CU (1)