18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery

NCT ID: NCT03821961

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2020-12-31

Brief Summary

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The aim of the study is to compare the endocrine function of pancreas between pre and post metabolic surgery in patients with type 2 diabetes or prediabetes. The study will examine the endocrine function of pancreas using 18F-FDOPA PET/CT imaging and various biochemical laboratory tests

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 PreDiabetes Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metabolic surgery

Roux-en-Y gastric bypass, Sleeve gastrectomy

Group Type EXPERIMENTAL

Metabolic Surgery

Intervention Type PROCEDURE

Roux-en-Y gastric bypass, Sleeve gastrectomy

Interventions

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Metabolic Surgery

Roux-en-Y gastric bypass, Sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes or prediabetes
* Body mass index \>25.0 kg/m2
* Written informed consent

Exclusion Criteria

* Diabetes induced by chronic pancreatitis or pancreas cancer
* Chronic glucocorticoid usage
* Significant coronary artery disease or cerebrovascular disease within the previous 3 months
* Uncompensated congestive heart failure
* Severe pulmonary disease defined as FEV1 \< 50% of predicted value
* End stage renal disease on dialysis
* Acute infectious disease within the previous 3 months
* Pulmonary thromboembolism or thrombophlebitis within the previous 3 months
* History of cancer (except for basal cell skin cancer or cancer in situ)
* Prior gastrointestinal surgery (except for appendectomy or hemorrhoidectomy)
* Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
* History of chronic liver disease (except for NAFLD/NASH)
* Psychiatric disorders including dementia, active psychosis, severe depression requiring \> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 5 years
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Myungmoon Pharma. Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sungsoo Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sungsoo Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yeongkeun Kwon, MD, PhD

Role: CONTACT

+82 2 920 5027

Facility Contacts

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Yeongkeun Kwon, MD, PhD

Role: primary

+82 2 920 5027

Other Identifiers

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STARDOM-PET

Identifier Type: -

Identifier Source: org_study_id

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