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

N/AUnknownNCT03821961

Korea University Anam Hospital30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 PreDiabetes Obesity

Interventions

Metabolic SurgeryPROCEDURE

Roux-en-Y gastric bypass, Sleeve gastrectomy

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Standardized Uptake Value

Time frame: 6 months

Secondary Outcomes

Change in Glycated Hemoglobin from baseline

percent change

Time frame: 6 months

Change in Fasting Plasma Glucose from baseline

percent change

Time frame: 6 months

Changes in c-peptide level from baseline

percent change

Time frame: 6 months

Changes in Insulinogenic index from baseline

(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)

Time frame: 6 months

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

(insulinfasting × glucosefasting)/405

Time frame: 6 months

Changes in Matsuda index from baseline

Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)

Time frame: 6 months

Change in Body Mass Index (BMI) from baseline

percent change

Time frame: 6 months

Change in Systolic Blood Pressure from baseline

percent change

Central Contacts

Yeongkeun Kwon, MD, PhD

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 6 months

Change in serum level of HDL cholesterol from baseline

percent change

Time frame: 6 months

Change in serum level of Triglycerides from baseline

percent change

Time frame: 6 months

Change in serum level of LDL cholesterol from baseline

percent change

Time frame: 6 months

Change in serum level of Total Cholesterol from baseline

percent change

Time frame: 6 months

Change in serum level of High-sensitivity C-reactive Protein

percent change

Time frame: 6 months

Change in number of diabetes medication from baseline

number of medication

Time frame: 6 months

Change in dosage of diabetes medication from baseline

Dosage of medication

Time frame: 6 months

Change in number of hypertension medication from baseline

number of medication

Time frame: 6 months

Change in dosage of hypertension medication from baseline

Dosage of medication

Time frame: 6 months

Change in number of dyslipidemia medication from baseline

number of medication

Time frame: 6 months

Change in dosage of dyslipidemia medication from baseline

Dosage of medication

Time frame: 6 months

Change in serum level of amino acid metabolites from baseline

glucose homeostasis and energy expenditure related metabolites

Time frame: 6 months

Change in BDI scores of questionnaire from baseline

Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)

Time frame: 6 months

Change in HDRS scores of questionnaire from baseline

Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 6 months