Does the Hematopoietic Stem Cell Govern Residual Inflamma... | NCT05597202

Studies
Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes

NCT05597202

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Unknown status

Last Update Posted

May 9, 2023Actual

Enrollment

22Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Semaglutide, 2.0 mg/mL

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Oct 14, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2023

Last Update Posted Date

May 9, 2023Actual

Name	Class
Dutch Heart Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.

Detailed Description

We will use 68Ga-Dotatate PET/CT scans, bone marrow aspirations and peripheral blood analyses to determine the effect of type 2 diabetes on vascular wall inflammation, and hematopoietic stem cell composition, and whether these changes can be reversed using high dose semaglutide treatment, up to 2.0mg subcutaneously per week, for a period of six months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	Will receive semaglutide treatment for 6 months, at the highest tolerable dose, up to a maximum of 2.0mg weekly.	Drug: Semaglutide, 2.0 mg/mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide, 2.0 mg/mL	Drug	Semaglutide 2.0 mg/mL, administered subcutaneously once per week for a period of 6 months.	Treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in coronary 68Ga-Dotatate uptake after treatment.	The within subject comparison of 68Ga-Dotatate uptake in the coronary arteries before and after semaglutide treatment, expressed as a difference in TBRmax.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Difference in bone marrow aspirates after treatment.	The within subject comparison of bone marrow aspirates before and after semaglutide treatment, expressed as a difference in stem cell count.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >50 years old
Diagnosed with type 2 diabetes
HbA1c >64mmol/mol

Exclusion Criteria:

(History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml
Auto-immune diseases (including type 1 diabetes)
Recent or chronic immunosuppressant or antibiotic usage
Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.
Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Uncontrolled hypertension (systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg)
Uncontrolled chronic inflammatory conditions, including gout.
Women of childbearing age who are not using effective contraceptives.
Heart failure New York Heart Association (NYHA) class IV at screening visit.
Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.
Pancreatitis in medical history.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
R.F. Oostveen, MD	Contact	020 5667050		r.oostveen@amsterdamumc.nl

Facility	Status	City	State	ZIP	Country	Contacts
AMC	Recruiting	Amsterdam	North Holland	1105AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided