Overweight and Obesity
Conditions
Keywords
Overweight, Obesity, Sodium pentaborate pentahydrate
Brief summary
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in improving the body weight and glycemic profile of patients with overweight or obesity compared to the placebo group.
Detailed description
Obesity is considered one of the pandemics of the current century which is associated with great mortality and morbidity. In addition to changing diet and physical activity, medicines, devices, and even surgery are suggested for obesity. Although they can be effective partially, however, the rate of recurrence is high and some are invasive. So, there is a need to evaluate other types of potential interventions for obesity management. Due to the effects of boron-derivates in the prevention and management of obesity, we will evaluate the safety and efficacy of sodium pentaborate pentahydrate in patients with overweight and obesity in terms of its safety and efficacy. This study will be conducted as a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 1/2 trial. Individuals aged ≥18 years with body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of hypertension or dyslipidemia will be recruited. Participants will be randomly assigned (1:1:1:1:1:1) to oral administration of once-daily sodium pentaborate pentahydrate (200, 400, 600, 800, 1000 mg), or placebo, using balanced block randomization. The primary endpoint will be the relative change from baseline in body weight (%) at 12 weeks. Adverse events will be monitored and checked closely in terms of physical examinations and laboratory measures.
Interventions
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
DRUGPlacebo
Placebo capsules
Sponsors
Tabriz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years at the time of signing the informed consent. * A non-pregnant female participant or a male participant who has been surgically sterilized (vasectomy) or is willing to use appropriate contraceptive methods during the trial (until the end of the trial). * Body mass index (BMI) ≥30·0 kg/m2 or BMI ≥27·0 kg/m2 in the presence of hypertension or dyslipidemia (treated or untreated, assessed at the discretion of the investigator).
Exclusion criteria
* Glycosylated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%) as measured by the laboratory at screening. * History of type 1 or type 2 diabetes. * Treatment with glucose-lowering drug(s) within 90 days prior to screening. * Obesity caused by endocrine disorders (such as Cushing's syndrome) * Change in body weight of more than 5 kg during the 90 days before screening regardless of medical records. * Treatment with any drug proven to control weight in the 90 days before screening. * Previous or planned obesity treatment (during the trial period) with surgery or a weight loss device. However, the following are permitted: (1) liposuction and/or abdominoplasty, if performed more than one year prior to screening; (2) lap banding, if the banding was removed more than 1 year before the screening. (3) intragastric balloon, if the balloon was removed more than 1 year before the screening. or (4) duodenal-jejunal bypass sleeve, if the sleeve was removed more than 1 year before the screening. * Uncontrolled thyroid disease, defined as TSH \>4·78 mIU/L or 1.5 times the upper limit of normal as measured by a laboratory at screening. * Inadequately treated hypertension, defined at screening as systolic ≥180 mmHg or diastolic ≥110 mmHg. * History of malignant neoplasms in the last 5 years before the screening. Basal and squamous cell skin cancer and any in situ cancer are allowed. * Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disturbances. * The participant is currently classified as having New York Heart Association Class IV heart failure. * Surgery planned during the trial period, excluding minor surgery, at the discretion of the investigator. * Known or suspected abuse of alcohol or recreational drugs. * Known or suspected hypersensitivity to test product(s) or related products. * Participation in another clinical trial within 90 days prior to screening. * Personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * Presence of acute pancreatitis within 180 days before screening. * History or presence of chronic pancreatitis. * Any impairment, unwillingness, or disability, not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of body weight | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | The relative change of body weight compared to the base weight (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Relative change in waist circumference compared to baseline |
| Change in body mass index | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Relative change in body mass index compared to baseline |
| Change of waist to hip circumference | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Relative change of waist to hip circumference compared to baseline |
| Hemoglobin A1c level | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Change in hemoglobin A1c level |
| Fasting blood glucose | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Change in fasting blood glucose levels |
| Insulin level | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Change in insulin level |
| Systolic and diastolic blood pressures | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in systolic and diastolic blood pressures |
| High density lipoprotein (HDL) levels | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in high density lipoprotein (HDL) levels |
| Low density lipoprotein (LDL) levels | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in low density lipoprotein (LDL) levels |
| Triglyceride levels | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in triglyceride levels |
| Total cholesterol levels | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in total cholesterol levels |
| High-sensitivity C-reactive protein levels | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in high-sensitivity C-reactive protein levels |
| Short-Form 36 (SF-36) v2·0 acute score | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in Short-Form 36 (SF-36) v2·0 acute scores. It ranges zero to 100 and lower scores mean higher disability. |
| Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2) | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Changes in Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2). It has four-point response scales ranging from definitely true (score = 4) to definitely false (score = 1). |
| Adverse events | Screening, randomization and weeks 2, 4, 6, 8, 10, 12 | Registration of adverse events in questionnaires |
Countries
Iran
Contacts
PRINCIPAL_INVESTIGATORSaeid Safiri, PhD
Tabriz University of Medical Sciences
Outcome results
None listed