Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission

January 12, 2022 updated by: Soroka University Medical Center

Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults with diabetes undergoing bariatric surgery. Subjects will be randomized to receive of intranasal oxytocin or placebo (8 units 3 times daily) for 8 weeks prior surgery. Study visits include screening to determine eligibility, CGM will be connected before and after oxytocin administration, and 1 year post surgery. blood tests including oral glucose tolerance test will be done and fat samples will be taken during surgery. The investigator's hypothesis is that oxytocin administration prior bariatric surgery can induce diabetes remission in patients with diabetes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 8410101
        • Soroka Unuversity Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65
  • Diabetes Mellitus type 2
  • HBA1C < or= 9
  • BMI >35
  • eligible for bariatric surgery (after a hospital bariatric committee)
  • Advanced diarem>6
  • Signed an informed consent -

Exclusion Criteria:

  • HBA1C above 9
  • Prior bariatric surgery in the past 6 years
  • secondary diabetes
  • steroid therapy
  • uncontrolled hypertension(>180/100)
  • Arythmia: paroxysmal tachyarythmia or high degree AV-Block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: oxytocin
8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Drug: Oxytocin
8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff
PLACEBO_COMPARATOR: placebo
intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Drug: placebo
8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with diabetes remission 1 year post surgery
Time Frame: 1 year post surgery
HBA1C less then 6.5% without need for diabetes medication
1 year post surgery
Number of participants who improved their glycemic control
Time Frame: 8 weeks
increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
8 weeks
weight loss
Time Frame: 8 weeks
weight reduction - kg.
8 weeks
weight loss
Time Frame: 1 year
weight reduction - kg.
1 year
obesity
Time Frame: 8 weeks
change in waist circumference
8 weeks
obesity
Time Frame: 1 year
change in waist circumference
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Insulin secretion
Time Frame: 8 weeks
Increase of insulin secretion after oxytocin administration
8 weeks
Rate of Insulin secretion
Time Frame: 1 year
Increase of insulin secretion after oxytocin administration
1 year
Rate of insulin resistance
Time Frame: 8 weeks
Increase of insulin sensitivity after oxytocin administration
8 weeks
Rate of insulin resistance
Time Frame: 1 year
Increase of insulin sensitivity after oxytocin administration
1 year
lipids-LDL CHOLESTEROL
Time Frame: 8 weeks
change in lipid profile: LDL
8 weeks
lipids-LDL CHOLESTEROL
Time Frame: 1 year
change in lipid profile: LDL
1 year
lipids-HDL CHOLESTEROL
Time Frame: 8 weeks
change in lipid profile: HDL
8 weeks
lipids-HDL CHOLESTEROL
Time Frame: 1 year
change in lipid profile: HDL
1 year
lipids-NON HDL CHOLESTEROL
Time Frame: 8 weeks
change in lipid profile: NON HDL cholesterol. triglycerides
8 weeks
lipids-NON HDL CHOLESTEROL
Time Frame: 1 year
change in lipid profile: NON HDL cholesterol. triglycerides
1 year
lipids-Triglycerides
Time Frame: 8 weeks
change in lipid profile: triglycerides
8 weeks
lipids-Triglycerides
Time Frame: 1 year
change in lipid profile: triglycerides
1 year
blood pressure
Time Frame: 8 weeks
change in systolic and diastolic blood pressure
8 weeks
blood pressure
Time Frame: 1 year
change in systolic and diastolic blood pressure
1 year
urine microalbumin
Time Frame: 8 weeks
Change in microalbumin/creatinin
8 weeks
urine microalbumin
Time Frame: 1 year
Change in microalbumin/creatinin
1 year
HPA axis
Time Frame: 8 weeks
change in cortisol
8 weeks
HPA axis
Time Frame: 1 year
change in cortisol
1 year
HPA axis
Time Frame: 8 weeks
change in ACTH
8 weeks
HPA axis
Time Frame: 1 year
change in ACTH
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: hrCRP
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: hrCRP
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: IL-6
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: IL-6
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: TNFα
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: TNFα
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: IL-1α
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: IL-1α
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: IL-1RA
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: IL-1RA
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: IL-17
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: IL-17
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: IL-21
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: IL-21
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: adiponectin
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers: adiponectin
1 year
systemic inflammation
Time Frame: 8 weeks
changes of inflammation markers: leptin
8 weeks
systemic inflammation
Time Frame: 1 year
changes of inflammation markers:leptin
1 year
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ASK1/2
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: LC3-II
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: family of ATGs
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:p-62
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TL-1A
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: IL-6
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PAI-1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control-PGK1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control PPIA
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: E2F1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: ASK1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: p-62
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: TRAL
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: TL-1A,
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: PEPD
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: PAI-1
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: family of ATGs
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
ELISA: adiponectin
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
ELISA: leptin
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
ELISA: TNF
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
ELISA: IL-6
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
histological studies :Adipocyte size distribution.
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
histological studies : CD68 staining
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
histological studies :,c-kit staining
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: adiponectin
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: leptin
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: TNF
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: IL-6
8 weeks
omental and subcutaneous fat inflammation
Time Frame: 8 weeks
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: CTRP6/12/2 (ng/ml).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Soroka University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ben-Gurion University of the Negev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOR-0041-18-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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