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SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes (SCOPE)

2026년 5월 25일 업데이트: Junjie Yang

Effects of SGLT2 Inhibitors on Coronary Atherosclerosis Progression in Diabetes Mediated by Perivascular Adipose Tissue: The SCOPE Trial

This study is a multicenter, randomized controlled trial to test whether an SGLT2 inhibitor (dapagliflozin), a type of diabetes medication, can slow down or even reverse the progression of coronary atherosclerosis (plaque buildup in the coronary arteries) in patients with type 2 diabetes. The effect may be mediated by improving the function of perivascular adipose tissue. A total of 144 adults with type 2 diabetes and stable coronary artery disease will be randomly assigned to receive either dapagliflozin plus standard diabetes and cardiovascular care (intervention group) or standard care alone (control group) for 18 months. Serial coronary CT angiography and other assessments will be performed to evaluate changes in coronary plaque volume, CT-derived fractional flow reserve, perivascular fat radiomics score, and various metabolic and inflammatory markers, to determine whether SGLT2 inhibition reduces cardiovascular risk.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Randomization and blinding: Eligible participants will be randomly assigned in a 1:1 ratio to either the dapagliflozin group or the standard care control group using a centralized, computer-generated randomization sequence. This is an open-label trial; however, all outcome assessments will be performed by core laboratories blinded to treatment allocation. Imaging analyses for plaque volume, hemodynamic parameters, and perivascular adipose tissue metrics will be conducted by investigators masked to group assignment.

Intervention: Participants in the intervention group receive dapagliflozin 10 mg once daily in addition to their standard diabetes and cardiovascular care. Participants in the control group receive standard glycemic management according to current clinical guidelines, with the exclusion of SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors. The total study duration is 18 months.

Study procedures: At baseline, participants will undergo coronary computed tomography angiography (CCTA) using a standardized protocol. Blood samples will be collected for lipid panels and inflammatory markers. Quality of life will be assessed using the Seattle Angina Questionnaire (SAQ-7). Follow-up visits are scheduled at 6, 12, and 18 months. At each visit, adverse events, concomitant medications, and medication adherence will be recorded. The 18-month visit will include a repeat CCTA and blood sampling.

Imaging core laboratory: All CCTA images will be transferred to an independent core laboratory for quantitative analysis. Plaque volume and composition will be assessed using semi-automated software. CT-derived fractional flow reserve (CT-FFR) will be computed using a dedicated algorithm. Wall shear stress (WSS) will be derived from computational fluid dynamics. Perivascular adipose tissue parameters, including fat attenuation index (FAI) and fat volume, will be measured using a validated software tool.

Data and safety monitoring: An independent Data and Safety Monitoring Board (DSMB) will review unblinded safety data every 6 months. The DSMB will monitor for serious adverse events, including volume depletion, genital infections, hypoglycemia, diabetic ketoacidosis, and acute kidney injury. Protocol-defined stopping rules include a significant increase in any of these events in the intervention arm.

연구 유형

중재적

등록 (추정된)

144

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국
        • 모병
        • The First Medical Center of Chinese PLA General Hospital
        • 연락하다:
      • Beijing, Beijing Municipality, 중국
        • 모병
        • The Sixth Medical Center of Chinese PLA General Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age between 18 and 75 years.
  • Confirmed diagnosis of type 2 diabetes mellitus with SCORE2-Diabetes risk score >10%.
  • Stable angina pectoris.
  • Coronary CT angiography (CCTA) demonstrating 50%-90% stenosis in at least one coronary vessel with diameter ≥2.5 mm.
  • CT-derived fractional flow reserve (CT-FFR) >0.8 in the target vessel.
  • Stable standard therapy for diabetes and cardiovascular disease, with no changes in SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors within the past 4 weeks.
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • History of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) with stenting, prosthetic valve replacement, or permanent pacemaker implantation.
  • New York Heart Association (NYHA) functional class III or IV heart failure. Acute myocardial infarction within the previous 30 days.
  • Known allergy to iodinated contrast media or other contraindications to CCTA. Severe arrhythmia or coronary artery calcium (CAC) score >400.
  • Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m². History of serious adverse reactions to SGLT2 inhibitors.
  • Pregnancy, lactation, or planned pregnancy during the study period. Severe liver dysfunction (Child-Pugh class C).
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SGLT2 Inhibitor Group
Participants with type 2 diabetes and coronary atherosclerosis receive dapagliflozin 10 mg orally once daily in addition to standard diabetes care for 18 months.
의약품: Dapagliflozin (DAPA)
Dapagliflozin 10 mg tablet administered orally once daily for 18 months, in addition to standard diabetes and cardiovascular care, to evaluate its effects on coronary atherosclerosis progression mediated by perivascular adipose tissue in patients with type 2 diabetes.
다른: Standard Care (Treatment as Usual)
Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months.
활성 비교기: Control Group
Participants receive standard diabetes care without SGLT2 inhibitors for 18 months.
다른: Standard Care (Treatment as Usual)
Standard glycemic and cardiovascular management according to clinical guidelines, excluding SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, for 18 months.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression of Coronary Plaque Volume and Proportion from Baseline to the 18-Month Follow-Up
기간: Baseline to 18 months
Progression of total plaque volume (TPV) （mm³）from baseline or appearance of new plaques, assessed by coronary CT angiography (CCTA). Includes changes in plaque components (e.g., necrotic core, fibrous cap, calcification)（mm³）.
Baseline to 18 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change in the Coronary Perivascular Fat Radiomics Score (FRS) from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in the coronary perivascular fat radiomics score (FRS), measured in "points", where a higher score indicates a higher inflammatory activity state and a stronger correlation with the risk of major adverse cardiovascular events.
Baseline to 18 months
Change in CT-derived fractional flow reserve (CT-FFR) from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in CT-derived fractional flow reserve (CT-FFR), expressed as a pure number between 0 and 1 (no units), where a higher value indicates a lower likelihood of ischemia.
Baseline to 18 months
Change in Fat Attenuation Index （FAI）from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in fat attenuation index (FAI)(HU) .FAI is defined as the mean attenuation value of pericoronary adipose tissue observed on CT scan, ranging from approximately -190 to -30 HU. Higher values indicating increased perivascular adipose tissue inflammation and coronary vulnerability, and lower values suggesting a more stable, anti-inflammatory vascular state.
Baseline to 18 months
Change in the Degree of Coronary Artery Stenosis from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in the degree of coronary artery stenosis, expressed as CAD-RADS category or quantitatively measured percent stenosis. CAD-RADS grades range from 0 to 5, with higher grades indicating greater stenosis severity. Quantitatively measured percent stenosis ranges from 0% to 100%, with higher percentages indicating greater stenosis severity.
Baseline to 18 months
Change in C-reactive protein (CRP) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in C-reactive protein (CRP). Reference range: 0-0.8 mg/L; Unit: mg/dL.
Baseline to 18 months
Change in Quality of Life Score as Assessed by the Seattle Angina Questionnaire (SAQ-7) from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in quality of life score measured by the Seattle Angina Questionnaire (SAQ-7). The total score ranges from 0 to 100, with higher scores indicating better quality of life and better angina control.
Baseline to 18 months
Occurrence of Major Adverse Cardiovascular Events (MACE) from Baseline to 18 Months
기간: Baseline to 18 months
Occurrence of major adverse cardiovascular events (MACE), including but not limited to cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, from baseline to the 18-month follow-up.
Baseline to 18 months
Change in Self-Rating Anxiety Scale（SAS） Score from Baseline to 18 Months
기간: Baseline to 18 months

Change from baseline to the 18-month follow-up in the Self-Rating Anxiety Scale (SAS) score. The SAS is a 20-item self-reported scale with 4-point scoring, designed to assess the subjective experience of anxiety in patients. Total scores range from 0 to 60, with higher scores indicating greater anxiety severity. The scores are interpreted as follows:

A (0-8): no anxiety disorder B (9-21): occasional anxiety C (22-32): mild anxiety disorder D (33-44): moderate anxiety disorder E (45-60): severe anxiety disorder
Baseline to 18 months
Change in Hamilton Anxiety Scale (HAMA) Score from Baseline to 18 Months
기간: Baseline to 18 months

Change from baseline to the 18-month follow-up in the Hamilton Anxiety Scale (HAMA) score. HAMA is a clinician-rated scale consisting of 14 items, each scored from 0 to 4, where:

0 = asymptomatic

  1. = mild symptoms
  2. = moderate symptoms (clearly present but does not affect daily life)
  3. = severe symptoms (significantly affects daily life)
  4. = extremely severe symptoms (unable to function normally)

Total scores range from 0 to 56, with higher scores indicating more severe anxiety. The score is interpreted as follows:

<7: no anxiety symptoms 7-13: possible anxiety 14-20: mild anxiety 21-28: marked anxiety 29: severe anxiety
Baseline to 18 months
Change in wall shear stress (WSS) from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in wall shear stress (WSS)(Pa).Both excessively high and abnormally low WSS are pathological: high WSS promotes plaque destabilization and rupture, while low WSS accelerates atherogenesis and plaque growth.
Baseline to 18 months
Change in Pericoronary Adipose Tissue Volume from Baseline to 18 Months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in Pericoronary Adipose Tissue Volume (mm³).Larger volume indicates higher inflammatory activity or greater disease burden, whereas smaller volume indicates the opposite.
Baseline to 18 months
Change in lipoprotein(a) (Lp(a)) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in lipoprotein(a) (Lp(a)). Reference range: <30 mg/dL; Unit: mg/dL.
Baseline to 18 months
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in low-density lipoprotein cholesterol (LDL-C). Reference range: 0-3.4; Unit: mmol/L.
Baseline to 18 months
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in high-density lipoprotein cholesterol (HDL-C). Reference range: 1-1.6 ; Unit: mmol/L.
Baseline to 18 months
Change in triglycerides (TG) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in triglycerides (TG). Reference range: 0.4-1.7; Unit: mmol/L.
Baseline to 18 months
Change in total cholesterol (TC) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in total cholesterol (TC). Reference range: 3.1-5.7; Unit: mmol/L.
Baseline to 18 months
Change in interleukin-6 (IL-6) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in interleukin-6 (IL-6). Reference range: 0-5.9 pg/mL; Unit: pg/mL.
Baseline to 18 months
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 18 months
기간: Baseline to 18 months
Change from baseline to the 18-month follow-up in tumor necrosis factor-alpha (TNF-α). Reference range: <20; Unit: ng/L.
Baseline to 18 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Junjie Yang

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 22일

QC 기준을 충족하는 최초 제출

2026년 5월 25일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 25일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • S2025-052-01
  • 82470342 (기타 보조금/기금 번호: National Natural Science Foundation of China)

개별 참가자 데이터(IPD) 계획

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아니요

IPD 계획 설명

Individual participant data will not be shared to protect participant privacy and confidentiality.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다