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

The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging

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

Study Overview

• Status: Unknown
• Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes
• Intervention / Treatment: Procedure: Metabolic Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Yeongkeun Kwon, MD, PhD; Phone Number: +82 2 920 5027; Email: kukwon@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metabolic surgery; Roux-en-Y gastric bypass, Sleeve gastrectomy	Procedure: Metabolic Surgery; Roux-en-Y gastric bypass, Sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Uptake value of 18F-FDOPA PET/CT from baseline	Standardized Uptake Value	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Hemoglobin from baseline	percent change	6 months
Change in Fasting Plasma Glucose from baseline	percent change	6 months
Changes in c-peptide level from baseline	percent change	6 months
Changes in Insulinogenic index from baseline	(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)	6 months
Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline	(insulinfasting × glucosefasting)/405	6 months
Changes in Matsuda index from baseline	Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)	6 months
Change in Body Mass Index (BMI) from baseline	percent change	6 months
Change in Systolic Blood Pressure from baseline	percent change	6 months
Change in serum level of HDL cholesterol from baseline	percent change	6 months
Change in serum level of Triglycerides from baseline	percent change	6 months
Change in serum level of LDL cholesterol from baseline	percent change	6 months
Change in serum level of Total Cholesterol from baseline	percent change	6 months
Change in serum level of High-sensitivity C-reactive Protein	percent change	6 months
Change in number of diabetes medication from baseline	number of medication	6 months
Change in dosage of diabetes medication from baseline	Dosage of medication	6 months
Change in number of hypertension medication from baseline	number of medication	6 months
Change in dosage of hypertension medication from baseline	Dosage of medication	6 months
Change in number of dyslipidemia medication from baseline	number of medication	6 months
Change in dosage of dyslipidemia medication from baseline	Dosage of medication	6 months
Change in serum level of amino acid metabolites from baseline	glucose homeostasis and energy expenditure related metabolites	6 months
Change in BDI scores of questionnaire from baseline	Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)	6 months
Change in HDRS scores of questionnaire from baseline	Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)	6 months
Change in SF-36 scores of questionnaire from baseline	36 Item Short Form Survery(Scale for quality of life)(Higer values represent a worse outcome) (Score range for physical health, 0-400) (Score range for mental health, 0-400)	6 months
Change in IWQOL scores of questionnaire from baseline	Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)	6 months
Change in MAQOL scores of questionnaire from baseline	Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)	6 months

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: Myungmoon Pharma. Co. Ltd.
• Investigators: Principal Investigator: Sungsoo Park, MD, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 26, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus, Type 2; PreDiabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: STARDOM-PET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No