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

Primary Purpose

Diabetes Mellitus, Type 2, PreDiabetes, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metabolic Surgery
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, PreDiabetes, Obesity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metabolic surgery

Arm Description

Roux-en-Y gastric bypass, Sleeve gastrectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2019
Last Updated
February 23, 2020
Sponsor
Korea University Anam Hospital
Collaborators
Myungmoon Pharma. Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03821961
Brief Title
18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery
Official Title
The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
Collaborators
Myungmoon Pharma. Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, PreDiabetes, Obesity
Keywords
Diabetes Mellitus, Type 2, PreDiabetes, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metabolic surgery
Arm Type
Experimental
Arm Description
Roux-en-Y gastric bypass, Sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Metabolic Surgery
Intervention Description
Roux-en-Y gastric bypass, Sleeve gastrectomy
Primary Outcome Measure Information:
Title
Change in Uptake value of 18F-FDOPA PET/CT from baseline
Description
Standardized Uptake Value
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Glycated Hemoglobin from baseline
Description
percent change
Time Frame
6 months
Title
Change in Fasting Plasma Glucose from baseline
Description
percent change
Time Frame
6 months
Title
Changes in c-peptide level from baseline
Description
percent change
Time Frame
6 months
Title
Changes in Insulinogenic index from baseline
Description
(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)
Time Frame
6 months
Title
Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline
Description
(insulinfasting × glucosefasting)/405
Time Frame
6 months
Title
Changes in Matsuda index from baseline
Description
Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)
Time Frame
6 months
Title
Change in Body Mass Index (BMI) from baseline
Description
percent change
Time Frame
6 months
Title
Change in Systolic Blood Pressure from baseline
Description
percent change
Time Frame
6 months
Title
Change in serum level of HDL cholesterol from baseline
Description
percent change
Time Frame
6 months
Title
Change in serum level of Triglycerides from baseline
Description
percent change
Time Frame
6 months
Title
Change in serum level of LDL cholesterol from baseline
Description
percent change
Time Frame
6 months
Title
Change in serum level of Total Cholesterol from baseline
Description
percent change
Time Frame
6 months
Title
Change in serum level of High-sensitivity C-reactive Protein
Description
percent change
Time Frame
6 months
Title
Change in number of diabetes medication from baseline
Description
number of medication
Time Frame
6 months
Title
Change in dosage of diabetes medication from baseline
Description
Dosage of medication
Time Frame
6 months
Title
Change in number of hypertension medication from baseline
Description
number of medication
Time Frame
6 months
Title
Change in dosage of hypertension medication from baseline
Description
Dosage of medication
Time Frame
6 months
Title
Change in number of dyslipidemia medication from baseline
Description
number of medication
Time Frame
6 months
Title
Change in dosage of dyslipidemia medication from baseline
Description
Dosage of medication
Time Frame
6 months
Title
Change in serum level of amino acid metabolites from baseline
Description
glucose homeostasis and energy expenditure related metabolites
Time Frame
6 months
Title
Change in BDI scores of questionnaire from baseline
Description
Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)
Time Frame
6 months
Title
Change in HDRS scores of questionnaire from baseline
Description
Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)
Time Frame
6 months
Title
Change in SF-36 scores of questionnaire from baseline
Description
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
Title
Change in IWQOL scores of questionnaire from baseline
Description
Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)
Time Frame
6 months
Title
Change in MAQOL scores of questionnaire from baseline
Description
Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeongkeun Kwon, MD, PhD
Phone
+82 2 920 5027
Email
kukwon@korea.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungsoo Park, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeongkeun Kwon, MD, PhD
Phone
+82 2 920 5027
Email
kukwon@korea.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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