Study of Immune Cells in Obese Patients With Type 2 Diabe... | NCT02201550

Studies
Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide

NCT02201550

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

Not provided

Countries

Denmark

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 24, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 28, 2014Estimated

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

Jul 24, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Name	Class
Zealand Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes.

The hypotheses are:

Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in the blood
Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood
Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine profile in the blood

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liraglutide		Patients with type 2 diabetes undertaking treatment with liraglutide

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in number of specific immune cells in blood detected by flow cytometry		Before and 12 weeks after initiation of liraglutide treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
BMI > 27 kg/m2
Planed start of treatment with liraglutide
Age > 18 years

Exclusion Criteria:

Infection or active inflammatory disorder
Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)
Smoking
Alcohol consumption > 14 beverages/week
Former bariatric surgery

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with type 2 diabetes undertaking treatment with liraglutide

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carsten Dirksen, MD, PhD	Hvidovre University Hospital	Principal Investigator
Sten Madsbad, MD, DMSc	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided