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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821961
• Other study ID #: STARDOM-PET
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Korea University Anam Hospital
• Contact: Yeongkeun Kwon, MD, PhD
• Phone: +82 2 920 5027
• Email: kukwon[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

Procedure:
• Metabolic Surgery
Roux-en-Y gastric bypass, Sleeve gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Myungmoon Pharma. Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Uptake value of 18F-FDOPA PET/CT from baseline	Standardized Uptake Value	6 months
Secondary	Change in Glycated Hemoglobin from baseline	percent change	6 months
Secondary	Change in Fasting Plasma Glucose from baseline	percent change	6 months
Secondary	Changes in c-peptide level from baseline	percent change	6 months
Secondary	Changes in Insulinogenic index from baseline	(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)	6 months
Secondary	Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline	(insulinfasting × glucosefasting)/405	6 months
Secondary	Changes in Matsuda index from baseline	Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)	6 months
Secondary	Change in Body Mass Index (BMI) from baseline	percent change	6 months
Secondary	Change in Systolic Blood Pressure from baseline	percent change	6 months
Secondary	Change in serum level of HDL cholesterol from baseline	percent change	6 months
Secondary	Change in serum level of Triglycerides from baseline	percent change	6 months
Secondary	Change in serum level of LDL cholesterol from baseline	percent change	6 months
Secondary	Change in serum level of Total Cholesterol from baseline	percent change	6 months
Secondary	Change in serum level of High-sensitivity C-reactive Protein	percent change	6 months
Secondary	Change in number of diabetes medication from baseline	number of medication	6 months
Secondary	Change in dosage of diabetes medication from baseline	Dosage of medication	6 months
Secondary	Change in number of hypertension medication from baseline	number of medication	6 months
Secondary	Change in dosage of hypertension medication from baseline	Dosage of medication	6 months
Secondary	Change in number of dyslipidemia medication from baseline	number of medication	6 months
Secondary	Change in dosage of dyslipidemia medication from baseline	Dosage of medication	6 months
Secondary	Change in serum level of amino acid metabolites from baseline	glucose homeostasis and energy expenditure related metabolites	6 months
Secondary	Change in BDI scores of questionnaire from baseline	Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)	6 months
Secondary	Change in HDRS scores of questionnaire from baseline	Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)	6 months
Secondary	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
Secondary	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
Secondary	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