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OpenTrials
Completed

NCT Number: NCT02145442

Effects of Obex in Overweight and Obese Patients

* 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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Weight Loss

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National Institute of Endocrinology

Plaza de la Revolución, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. To evaluate the effect of Obex® on fasting insulin levels

    Time frame: Three months of treatment

    The insulin levels will be evaluated at baseline and at the end of treatment.

  2. • 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

    The HOMA-IR will be evaluated at baseline and at the end of treatment.

  3. 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

    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])

  4. • 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

    The HOMA-B will be evaluated at baseline and at the end of treatment

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

    Time frame: Three months of treatment

    The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment.

  6. To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)

    Time frame: Three months of treatment

    The HbA1c will be evaluated at baseline and at the end of treatment.

  7. To evaluate the effect of Obex® on the body weight.

    Time frame: Three months of treatment

    The body weight will be measured at baseline and at the end of treatment.

  8. • To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)

    Time frame: Three months of treatment

    The BMI and CI will be measured at baseline and at the end of treatment.

  9. To evaluate the effect of Obex® on the waist and hip circumferences

    Time frame: Three months of treatment

    Waist and Hip circumferences will be measured at baseline and at the end of treatment.

  10. To evaluate the effect of Obex® on arterial blood pressures (BP)

    Time frame: Three months of treatment

    The arterial BP will be evaluated at baseline and at the end of treatment.

  11. • To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)

    Time frame: Three months of treatment

    The hepatic enzymes will be evaluated at baseline and at the end of treatment.

  12. To evaluate the effect of Obex® on creatinine and uric acid concentrations

    Time frame: Three months of treatment

    The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment.

  13. To evaluate the effect of Obex® on haemoglobin and serum iron levels

    Time frame: Three months of treatment

    The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment.

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 23, 2014
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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