Fixed Dose Combination of Fluoxetin and Metformin in the Management of Overweight and Obesity
Fixed Dose Combination of Fluoxetin and Metformin in the Management of Overweight and Obesity
Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel
 groups, randomized treatment to assess the efficacy and safety using a fixed dose combination
 of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or
 overweight in order to generate new knowledge and give a greater number of therapeutic
 options to the clinicians, one group will receive metformin 1700 mg and 40 mg of fluoxetine;
 Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a third group
 called control will receive placebo.

 The above described treatments will be administered according to the "Dosage Schedule" The
 three groups will receive tablets of physical characteristics equal to the reference drug to
 preserve the blinding.
Overweight and obesity are serious health problems that affect population around the world.
 According to information of the World Health Organization (WHO) in 2014 more than 1.9 billion
 of inhabitants older than 18 years had overweight, of which 600 million were obese, i.e., 39%
 of adults at global level present overweight and 13% of adults suffer obesity.

 Overweight and obesity are considered complex and multifactorial diseases associated with the
 development of multiple co-morbidities such as certain types of cancer, cardiovascular
 diseases (CVD), disability, diabetes mellitus type 2 (DM2), disease of gallbladder,
 osteoarthritis, high blood pressure (Hypertension), sleep apnea and cerebrovascular disease
 (CD), making it the fifth leading cause of death worldwide , and is therefore considered a
 pandemic.

 Obesity is defined as the increase of the weight body associated to an imbalance in the
 proportions of the different components of the body, in which mainly, the mass fat increases
 with abnormal distribution in the body.The Body Mass Index (BMI) is the standard most widely
 used for the classification of the somatotype in the people, and therefore the identification
 of obesity. BMI is obtained through by dividing the weight in kilograms between heights in
 squared meters. The classification of the BMI for White, Hispanic, and African-American adult
 people has been approved by the National Institute of Heart, Lung and Blood, the WHO, the
 American Association of Heart, the American College of Cardiology and the Obesity Society,
 whose classification is the following:

 The weight body is determined by the balance energy, which represents the difference between
 the intake of energy through the food and the expenditure of energy coming of physical
 activity of an individual. For the maintenance of a stable body weight, the energy intake
 must be equal to energy expenditure, that's when weight gain happens, when the intake exceeds
 expenditure, which produces a positive energy balance. On the other hand, weight loss occurs
 when energy expenditure exceeds the caloric intake.

 Although the low expenditure of energy represents one of the main factors that produce an
 increase in the weight, there are multiple factors that play an important role. These factors
 include genetic predisposition of the individual, physical inactivity and sedentary behavior,
 socio-economic factors, as well as emotional factors and consumption of certain types of
 drugs.

 Due to the multiple factors that have an influence in the development of overweight and
 obesity, the treatment is complex, because there must be some type of treatment by a
 multidisciplinary team that achieve the control of each one of the factors that condition
 obesity of each individual.

 Traditional treatments for loss weight have been given in the education of the individual on
 the preference for healthy foods, prescription diets and the implementation of programs of
 physical activity. However, various studies have shown that this type of intervention has few
 effects in long term, so the incorporation of new strategies as adjuvants in the loss of
 weight have been developed, which include surgical techniques and pharmacological therapies.

 According to the guidelines for obesity, the drug treatment therapy should be recommended in
 individuals with a BMI ≥30 kg/m2 or with a BMI of ≥27 kg/m2 and the presence of a
 comorbidity. 6. The use of pharmacological therapies must always be used as adjuvants to
 changes in lifestyle, and must be approved by health authorities of each country. Before
 2012, phentermine and orlistat were the unique medications available for the treatment of
 obesity in the United States; however in 2015 the Repertoire of pharmacological agents
 available to treat the obesity was extended and incorporated 4 new drugs: lorcaserin,
 phentermine / topiramate of prolonged release, naltrexone / wellbutrin of prolonged release
 and liraglutide. These new drugs share a common strategy to promote weight loss that controls
 hunger and satiation at the level of the central nervous system (CNS), besides that most of
 them have been previously used for the treatment of a medical condition other than obesity.
 The amount of weight lost that is achieved through the use of these agents, usually goes from
 3 to 10% of the initial weight and requires a continuous to hold the loss of weight. In
 addition, each of these drugs has a unique profile of adverse events that should be
 considered deeply prior to be indicated.

 Due to the above, the search for new drug therapies for the obesity treatment is one of the
 priorities in the research. Some drugs developed for different therapeutic indications have
 shown significant effects on weight loss, which include metformin hydrochloride and
 fluoxetine
Inclusion Criteria:

 -  Signature of consent informed

 -  Men and Women.

 -  ≥ 18 years old proven through a current official identification.

 -  BMI ≥ 30 kg/m2 with or without Comorbidities.

 -  BMI ≥ 27 kg/m2 with a diagnosis of comorbidities by patient's clinical record
 associated with overweight (DM2's recent diagnosis without treatment, hypertension,
 dyslipidemia, sleep apnea or secondary heart disease) defined as follows:

 -  DM2 of current diagnosis study inclusion unless not receive drug treatment, with a
 HbA1c ≥6. 5 and and < 8.5%.

 -  Arterial Systemic Hypertension with figures < 140 / 90 mmHg.

 -  Dyslipidemia with total cholesterol levels> 200 mg / dl and <240 mg / dl, and / or
 LDL-C> 100 and <160 mg / dl and / or triglycerides> 150 mg / dl and <400 mg / dl.

 -  In case of have drug treatment for hypertension or dyslipidemia, the participants must
 have a stable dose for at least 3 months prior to the elective visit.

 -  Women in childbearing age must use a reliable method of birth control, such as barrier
 methods (condom, diaphragm), fallopian tube obstruction, intrauterine device.

 Exclusion Criteria:

 -  Endogenous obesity (endocrine diseases that condition gain of weight, such as
 hypothyroidism, syndrome of Cushing).

 -  Background of patient's clinical record history of iatrogenic obesity (use of drugs
 that determine weight gain, such as corticosteroids, antipsychotic and antiepileptic).

 -  Thyroid stimulating Hormone (TSH) is out of range.

 -  Prolongation of the QT interval corrected for rate (QTc) segment by electrocardiogram
 with the formula of prolonged Bazett (greater than 450 msec. in males and 470 msec in
 women).

 -  Creatinine ≥1. 3 mg/dl in women and ≥1. 5 mg/dl in men.

 -  Alanine transaminase(ALT) or Aspartate Aminotransferase (AST) > 2 times above from the
 normal value.

 -  Background of patient's clinical record of depressive disorder or anxiety that - may
 require therapy with psychiatric drugs.

 -  Intolerance known to drugs in the study.

 -  Pregnancy or breastfeeding.

 -  Use of medications, supplements or other techniques whose objective is the reduction
 of weight.

 -  Use of medications contraindicated with drugs study.