Protocol summary

Study aim
Evaluation of the safety and effectiveness of sodium pentaborate pentahydrate in overweight and obese people
Design
A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial on 120 participants. Using balanced block randomization, patients will be enrolled in one of the two groups
Settings and conduct
This study will be conducted in hospitals affiliated with Tabriz University of Medical Sciences. Individuals over 18 years of age with a body mass index (BMI) ≥30.0 kg/m2 or a BMI ≥27.0 kg/m2 in the presence of hypertension or dyslipidemia will be selected. Participants were randomized (6:1) to oral administration of NaB once daily (200, 400, 600, 800, 1000 mg), or the corresponding placebo, using balanced block randomization. The primary objective will be the relative change in body weight (percentage) from baseline at week 12. Adverse effects will be carefully monitored and evaluated in terms of physical examinations and laboratory procedures.
Participants/Inclusion and exclusion criteria
Individuals with body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with hypertension or dyslipidemia will be included in the study. People with a history of diabetes, obesity caused by endocrine disorders, or a weight change of more than 5 kg in the last three months, or receiving medication for weight loss, will not be included.
Intervention groups
Five intervention groups (use of sodium pentaborate pentahydrate once a day in one of 5 doses (200, 400, 600, 800, 1000 mg)) and one placebo group will receive drugs of the same shape, smell and color.
Main outcome variables
Change of body weight compared to base weight; Proportion of people with weight loss ≥ 5% of the initial body weight; Proportion of people with weight loss ≥ 10% of the initial body weight; waist to hip ratio; BMI change (kg/m2); HbA1c change; Changes in fasting plasma glucose

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220614055167N3
Registration date: 2023-02-14, 1401/11/25
Registration timing: prospective

Last update: 2023-02-14, 1401/11/25
Update count: 0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Saeid Safiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3332 7195
Email address
saeidsafiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesity: a randomised, double-blind, placebo-controlled phase 1/2 trial
Public title
Safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesity
Purpose
Treatment
Inclusion/Exclusion criteria
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 due to endocrine disorders (eg, Cushing's syndrome) A change in body weight of more than 5 kg within 90 days prior to screening regardless of medical record Treatment with any medication proven to control weight within 90 days prior to screening Treatment of obesity 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 screening Uncontrolled thyroid disease, defined as TSH >4.78 mIU/L or 1.5 times the upper limit of normal, which is measured by the laboratory in the screening Undertreated hypertension, defined at screening as systolic ≥180 mmHg or diastolic ≥110 mmHg 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 exclusion criteria, that in the opinion of the investigator may compromise the participant's safety or compliance with the protocol.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization, patients will be assigned to intervention groups or placebo groups. The randomization sequence will be determined by one of the individuals who did not participate in the current research. It is necessary to explain that the aforementioned randomization method reduces the possibility of predicting and manipulating the randomization process by people to zero and will lead to the balance of the size of the groups during and at the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will receive the boxes sealed with 10-digit codes and will receive the original drug or placebo, and they will not be aware of the type of received material. The researcher will ensure the blinding of the patients. Also, doctors, researchers, and those responsible for the implementation of the project will not be aware of the type of medicine received by the patients until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Azadi St, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.TBZMED.REC.1401.1014

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
The relative change of body weight compared to the base weight (%)
Timepoint
Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Scale

Secondary outcomes

1

Description
Proportion (%) of people with weight loss ≥ 5% of initial body weight
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Scale

2

Description
Proportion (%) of people with weight loss ≥ 10% of initial body weight
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Scale

3

Description
Relative change in waist circumference compared to baseline
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Tape measure

4

Description
Relative change in body mass index compared to baseline
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Scale and tape measure

5

Description
Relative change of waist to hip circumference compared to baseline
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Tape measure

6

Description
Hemoglobin A1c level
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
HbA1c Reagent Kit

7

Description
Fasting blood glucose
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Glucometer

8

Description
Insulin level
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Human Insulin ELISA Test Kit

9

Description
Systolic and diastolic blood pressure
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Digital manometer

10

Description
High density lipoprotein (HDL) levels
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Laboratory kits

11

Description
Low density lipoprotein (LDL) levels
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Laboratory kits

12

Description
Triglyceride level
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Laboratory kits

13

Description
Total cholesterol levels
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Laboratory kits

14

Description
High-sensitivity C-reactive protein level
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Laboratory kits

15

Description
Quality of life related to general health
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Short-Form 36 (SF-36) v2·0 acute score change

16

Description
Weight-related quality of life
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Three-Factor Eating Questionnaire Revised 18-item version 2 score change (TFEQ-R18v2)

17

Description
Adverse events
Timepoint
Weeks 2, 4, 6, 8, 10, 12, 16
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Capsules containing sodium pentaborate pentahydrate 200 mg
Category
Treatment - Drugs

2

Description
Intervention group: Capsules containing sodium pentaborate pentahydrate 400 mg
Category
Treatment - Drugs

3

Description
Intervention group: Capsules containing sodium pentaborate pentahydrate 600 mg
Category
Treatment - Drugs

4

Description
Intervention group: Capsules containing sodium pentaborate pentahydrate 800 mg
Category
Treatment - Drugs

5

Description
Intervention group: Capsules containing sodium pentaborate pentahydrate 1000 mg
Category
Treatment - Drugs

6

Description
Control group: Placebo capsules
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 5566 8474
Email
saeidsafiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5155668474
Phone
+98 41 3335 5948
Email
saeidsafiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
516615731
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
516615731
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
516615731
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the information will be available to all after publishing without the personal information of participants.
When the data will become available and for how long
After publishing the papers
To whom data/document is available
All researchers that are confirmed by the principal investigator
Under which criteria data/document could be used
All of the data will be available except the personal information of the participants
From where data/document is obtainable
Applicants can initially communicate with the principal investigator's email that is available in this protocol, and if there is no response within a week, a reminder email will be sent again. If they still do not receive an answer, they can call the relevant contact number or send a letter to the listed postal address.
What processes are involved for a request to access data/document
It is evaluated by the team and the principal investigator will inform those who requested
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