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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03821961
Other study ID # STARDOM-PET
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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