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

K

Korea University

Status

Unknown

Conditions

Obesity
Diabetes Mellitus, Type 2
PreDiabetes

Treatments

Procedure: Metabolic Surgery

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03821961
STARDOM-PET

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Metabolic surgery
Experimental group
Description:
Roux-en-Y gastric bypass, Sleeve gastrectomy
Treatment:
Procedure: Metabolic Surgery

Trial contacts and locations

1

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Central trial contact

Yeongkeun Kwon, MD, PhD

Data sourced from clinicaltrials.gov

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