NCT03821961

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

January 22, 2019

Last Update Submit

February 23, 2020

Conditions

Diabetes Mellitus, Type 2PreDiabetesObesity

Keywords

Diabetes Mellitus, Type 2PreDiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • Change in Uptake value of 18F-FDOPA PET/CT from baseline

    Standardized Uptake Value

    6 months

Secondary Outcomes (25)

  • Change in Glycated Hemoglobin from baseline

    6 months

  • Change in Fasting Plasma Glucose from baseline

    6 months

  • Changes in c-peptide level from baseline

    6 months

  • Changes in Insulinogenic index from baseline

    6 months

  • Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline

    6 months

  • +20 more secondary outcomes

Study Arms (1)

Metabolic surgery

EXPERIMENTAL

Roux-en-Y gastric bypass, Sleeve gastrectomy

Procedure: Metabolic Surgery

Interventions

Metabolic SurgeryPROCEDURE

Roux-en-Y gastric bypass, Sleeve gastrectomy

Metabolic surgery

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateObesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Sungsoo Park, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeongkeun Kwon, MD, PhD

CONTACT

+82 2 920 5027kukwon@korea.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 30, 2019

Study Start

September 3, 2018

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)