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hUC-MSC-Exosomes for T2DM - Safety & Efficacy (HOPE-T2DM)

3 luglio 2026 aggiornato da: Peking University First Hospital

An Exploratory Clinical Study Assessing the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus

The goal of this clinical trial is to Evaluate the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

A two-stage, progressive mixed design will be adopted to balance ethical considerations and scientific rigor.

Stage 1 (Open-Label, Before-and-After Study) will employ a sequential, open-label dose-escalation design:

A total of 18 patients will be enrolled, all receiving a 2-month course (once weekly, 8 doses total) of intravenous exosome infusion therapy. This study uses a sequential dose-escalation design with three dose cohorts: low-dose (1×10¹¹ particles), medium-dose (3×10¹¹ particles), and high-dose (9×10¹¹ particles). Dose escalation will strictly adhere to the following procedure:

Sequential Progression: The study for the next dose cohort can only commence after all subjects in the previous dose cohort have completed the required safety observation period (i.e., the 5-week follow-up post-last dose) and the safety data has been reviewed.

Stage 2 (Randomized, Double-Blind, Active-Comparator Parallel Study):

Provided no major safety issues are identified in the first stage, the second stage will commence. This stage plans to enroll 48 patients, randomized 2:1 to either the exosome treatment group (n=32) or the active-comparator control group (n=16).

Follow-up Plan: Multiple visits are scheduled, including a baseline period, treatment period (after each dose), end of treatment (Week 8/Month 2), and post-treatment follow-up periods (Week 12, Month 3, Month 6, Month 12), to systematically evaluate efficacy and safety.

Tipo di studio

Interventistico

Iscrizione (Stimato)

66

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Beijing, Cina
        • Reclutamento
        • Peking University First Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Age 18-65 years, diagnosed with T2DM for ≥5 years (<20 years).
  2. Regular diet and exercise control combined with the following intensive treatment regimens, with screening HbA1c remaining between 7.5% and 9.0% (FBG <13.9mmol/L):Stable dose of insulin (basal or premixed) (<1.5u/kg·d) combined with ≥1 oral antidiabetic drug (OAD) (e.g., Metformin, SGLT2i) for ≥3 months; or Insulin combined with a GLP-1RA (maximum tolerated dose, ≤1mg Qw); or GLP-1RA (maximum tolerated dose, ≤1mg Qw) combined with ≥1 OAD for ≥3 months; or Stable dose of ≥3 OADs (must include Metformin) for ≥3 months.
  3. Fasting C-peptide ≥1.0 ng/mL.
  4. Glutamic acid decarboxylase (GAD) antibody and Islet cell antibody (IAA) negative.
  5. Body Mass Index (BMI) 18.5-35 kg/m ².
  6. Subjects voluntarily participate in the study and sign the informed consent form.
  7. Female subjects of childbearing potential and non-sterilized male subjects must agree to use highly effective contraceptive methods during the study period and for 1 year following the final infusion.

Exclusion Criteria:

  1. Type 1 diabetes or other specific types of diabetes.
  2. Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months.
  3. Severe cardiovascular/cerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR <30 mL/min·1.73m²).
  4. Active malignancy, coagulation disorders, immune system diseases.
  5. Pregnant or lactating women.
  6. Individuals with allergic constitution.
  7. Exclusion of subjects currently participating in other clinical trials.
  8. Subjects deemed unsuitable for participation by the investigator.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: gruppo di controllo
Altro: control group
active-comparator control：（n=16）The control group will receive an equal volume of the same buffer solution without exosomes (.Subjects in this groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses)
Altri nomi:
  • active-comparator
Sperimentale: exosomes treatment group
GoldenExo（NATX） treatment
Biologico: exosomes treatment group
GoldenExo（NATX） treatment group (n=32) The specific therapeutic dose for the second stage will be evaluated and determined jointly by the investigators and the Safety Monitoring Committee (SMC) after all three dose escalation trials (1×10¹¹, 3×10¹¹, 9×10¹¹ particles) in the first stage.Subjects in both groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses).
Altri nomi:
  • GoldenExo（NATX） treatment group

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Glycated Hemoglobin (HbA1c)
Lasso di tempo: Baseline, Week 8

The primary efficacy endpoint is the change in glycated hemoglobin (HbA1c) from baseline to Week 8. In the randomized comparative stage, between-group differences between the investigational intervention group and the control group will also be evaluated.

Unit of Measure: Percentage (%)

Interpretation:

Reflects long-term glycemic control and overall metabolic efficacy of the intervention.
Baseline, Week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glycated Hemoglobin (HbA1c) Response Rate
Lasso di tempo: Week 24, Week 52

Proportion of participants achieving HbA1c target control. Definition: HbA1c < 7.0% Unit of Measure: Percentage of participants (%)

Interpretation:

Reflects long-term glycemic target attainment rate.
Week 24, Week 52
Pancreatic Islet Function: Insulin (INS)
Lasso di tempo: Baseline, Week 4, Week 8，Week 12, Week 24, Week 52

Comparison of serum/plasma insulin levels between baseline and various post-treatment follow-up time points via synchronous venous blood sampling at fasting.

Unit of Measure:Picomoles per liter (pmol/L). Interpretation:Used to evaluate circulating insulin levels. HOMA-IR assesses the sensitivity of peripheral target tissues (skeletal muscle, liver, adipose tissue) to insulin, where higher values indicate more severe resistance. HOMA-beta statically evaluates baseline pancreatic beta-cell secretory function under fasting conditions (applicable to subjects not receiving exogenous insulin therapy).
Baseline, Week 4, Week 8，Week 12, Week 24, Week 52
Pancreatic Islet Function: C-peptide
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Comparison of serum/plasma C-peptide levels between baseline and various post-treatment follow-up time points, measured synchronously from venous blood at fasting.

Unit of Measure:Nanograms per milliliter (ng/mL) Interpretation:Used to evaluate endogenous insulin secretion. Because C-peptide bypasses hepatic first-pass metabolism, it precisely mirrors true residual endogenous pancreatic beta-cell mass and functional capacity. An increase from baseline (positive change) indicates functional recovery or preservation of pancreatic beta-cells.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Changes in Blood Glucose during MMTT
Lasso di tempo: Baseline, Week 8, Week 52

Fasting (0 min) and 2-hour postprandial (120 min) blood glucose levels are measured during mixed-meal tolerance test (MMTT). Changes from baseline at various post-treatment follow-up time points are compared.

Unit of Measure: mmol/L Interpretation: Lower postprandial glucose levels and/or reduced glucose excursion during MMTT indicate improved glycemic control and β-cell function.
Baseline, Week 8, Week 52
Anthropometric and Metabolic Parameters
Lasso di tempo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 52

Assessment of body composition and metabolic status. Body Mass Index (kg/m²)

Interpretation:

Reflects systemic metabolic control and cardiometabolic risk profile.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 52
Soluble Adhesion Molecule (sICAM-1)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Serum levels of soluble intercellular adhesion molecule-1 (sICAM-1) as a marker of endothelial activation.

Unit of Measure: ng/mL

Interpretation:

Reflects endothelial dysfunction and vascular inflammatory activity.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Ophthalmologic Assessment
Lasso di tempo: Baseline, Week 24

Assessment of diabetic retinopathy using fundus photography and standardized grading.

Unit of Measure: Clinical staging 5, listed below

Interpretation:

Reflects progression or stabilization of retinal microvascular disease.

  1. No apparent retinopathy / No diabetic retinopathy (No DR)
  2. Mild non-proliferative diabetic retinopathy (Mild NPDR)
  3. Moderate non-proliferative diabetic retinopathy (Moderate NPDR)
  4. Severe non-proliferative diabetic retinopathy (Severe NPDR)
  5. Proliferative diabetic retinopathy (PDR)
Baseline, Week 24
Change in Central Obesity: Waist-to-Hip Ratio (WHR)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Evaluation of changes in waist and hip circumferences to calculate the Waist-to-Hip Ratio (WHR), comparing baseline measurements with various post-treatment follow-up time points to quantify central obesity (visceral fat accumulation).

Unit of Measure:Centimeters (cm) for raw circumferences; Ratio is dimensionless. (Normal reference range: Male < 0.9, Female < 0.85) .

Interpretation:A classic anthropometric clinical index for assessing visceral adiposity. A decrease from baseline (negative change) indicates targeted reduction in abdominal fat and metabolic risk alleviation.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Body fat percentage (%)
Lasso di tempo: Baseline, Week 8, Week 24, Week 52
Comparison of the body fat percentage between baseline and various post-treatment follow-up time points to evaluate quantitative and qualitative shifts in overall body composition. Normal reference range: Male （10%~20%）, Female （20%~30%） Unit of Measure:Percentage (%) Interpretation:Used to differentiate whether total body weight fluctuations stem from a true reduction in adipose tissue mass or the unintended, unorganized loss of lean muscle mass. A decrease from baseline (negative change) represents a favorable structural metabolic improvement.
Baseline, Week 8, Week 24, Week 52
C-Reactive Protein (CRP)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Description: Comparative monitoring of systemic immune cell populations (leukocyte subsets) and C-Reactive Protein (CRP) absolute concentrations between baseline and post-treatment points.

Unit of Measure:Milligrams per liter (mg/L) (Note: Units to be finalized based on specific laboratory assay methods and markers selected).

Interpretation:Tracks acute infectious episodes, systemic clinical flare-ups, or subclinical active inflammatory processes relative to baseline safety thresholds.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Time in Range (TIR, 3.9-10.0 mmol/L)
Lasso di tempo: baseline to week 8

Description:

Continuous glucose monitoring (CGM) is used to assess 24-hour interstitial glucose dynamics Unit of Measure: % (TIR)

Interpretation:

Reflects short-term glycemic stability and variability control.
baseline to week 8
Mean glucose level
Lasso di tempo: baseline to week 8

Description:

Continuous glucose monitoring (CGM) is used to assess 24-hour interstitial glucose dynamics Unit of Measure: mmol/L

Interpretation:

Reflects short-term glycemic stability and variability control.
baseline to week 8
Coefficient of variation (CV%)
Lasso di tempo: Baseline to week 8

Continuous glucose monitoring (CGM) is used to assess 24-hour interstitial glucose dynamics Unit of Measure: %

Interpretation:

Reflects short-term glycemic stability and variability control.
Baseline to week 8
Inflammatory Biomarkers：Interleukin-4 (IL-4)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A classic Th2-type anti-inflammatory cytokine modulating adaptive immune differentiation. Longitudinal alterations in serum IL-4 values will be evaluated using multiplex assays to assess Th2 immune response and inflammation alleviation effect.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Moderate IL-4 expression balances Th1/Th2 immune axis and suppresses excessive pro-inflammatory reaction. Declined IL-4 level leads to immune imbalance and aggravated inflammatory progression.

Unit of Measure: pg/mL

Interpretation:

Reflects systemic low-grade inflammation and immune modulation.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-6（ IL-6）
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A multifunctional pleiotropic pro-inflammatory cytokine linking innate and adaptive immunity. Longitudinal alterations in serum IL-6 values will be evaluated using multiplex assays to monitor dynamic systemic inflammatory fluctuation and therapeutic inflammatory improvement.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Serum IL-6 concentration is positively correlated with the severity of systemic low-grade inflammation. Persistently elevated IL-6 facilitates inflammatory cell aggregation and chronic tissue pathological remodeling.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin- 1β (IL-1β)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

An early activated pro-inflammatory cytokine released by activated macrophages. Longitudinal alterations in serum IL-1β values will be evaluated using multiplex assays to assess the initiation degree of upstream inflammatory signaling pathways.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Elevated IL-1β triggers downstream cascade inflammatory activation, induces systemic inflammatory pain and tissue degeneration, and indicates active early low-grade inflammatory stimulation.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-10 (IL-10)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A pivotal anti-inflammatory cytokine secreted mainly by regulatory T cells and macrophages. Longitudinal alterations in serum IL-10 values will be evaluated to assess endogenous anti-inflammatory capacity and intervention-induced immune negative regulation.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Physiologically elevated IL-10 inhibits overactivated inflammatory cascade and reduces tissue inflammatory damage. Insufficient serum IL-10 expression breaks immune homeostasis, exacerbates systemic low-grade inflammation, and prolongs inflammatory pathological status.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-8 (IL-8)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A potent chemotactic pro-inflammatory cytokine targeting neutrophil migration. Longitudinal alterations in serum IL-8 values will be evaluated using multiplex assays to assess local and systemic inflammatory cell recruitment level.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Increased IL-8 induces massive inflammatory cell infiltration into tissues, amplifies local inflammatory lesions, and maintains chronic persistent low-grade inflammatory status in vivo.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-2 (IL-2)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A key lymphocyte-derived pro-inflammatory cytokine regulating T-cell proliferation and activation. Longitudinal alterations in serum IL-2 values will be evaluated using multiplex assays to assess peripheral T lymphocyte immune activation status.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Abnormally elevated IL-2 mediates excessive effector T-cell activation, enhances inflammatory immune attack, and participates in the occurrence and development of immune-mediated inflammatory lesions
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Tumor Necrosis Factor-alpha (TNF-α)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A core pro-inflammatory cytokine derived from monocytes and macrophages. Longitudinal alterations in serum TNF-α values will be evaluated using multiplex assays to assess systemic inflammatory activation degree and inflammatory injury level.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Sustained high serum TNF-α level drives persistent systemic low-grade inflammation, induces cellular apoptosis and visceral tissue damage, and acts as a key biomarker reflecting chronic inflammatory disease activity.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interferon-gamma (IFN-γ)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A typical type 1 pro-inflammatory cytokine produced by T lymphocytes and natural killer cells. Longitudinal alterations in serum IFN-γ values will be evaluated using multiplex assays to assess cellular immune activation and pro-inflammatory immune polarization.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Excess IFN-γ triggers Th1-type immune hyperactivation, promotes inflammatory cell infiltration, aggravates autoimmune and inflammatory responses, and predicts poor immune regulatory status.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interferon-alpha (IFN-α)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

An innate immune-derived pro-inflammatory interferon primarily secreted by plasmacytoid dendritic cells. Longitudinal alterations in serum IFN-α values will be evaluated using multiplex assays to assess innate immune activation and early inflammatory response.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Upregulated IFN-α activates innate immune cascade reaction, induces systemic inflammatory cascade, and is closely associated with chronic low-grade inflammation and immune overreaction.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers： Interleukin-17A（IL-17A）
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A signature pro-inflammatory cytokine secreted by Th17 cells. Longitudinal alterations in serum IL-17A values will be evaluated using multiplex assays to assess Th17-mediated inflammatory response and mucosal inflammatory injury.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: High-level IL-17A breaks immune tolerance, promotes pro-inflammatory mediator release, and is a core biomarker for aggravated chronic inflammatory and autoimmune pathological changes.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-12p70 (IL-12p70)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A heterodimeric pro-inflammatory cytokine driving Th1 cell differentiation. Longitudinal alterations in serum IL-12p70 values will be evaluated using multiplex assays to assess Th1 immune axis differentiation bias.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Upregulated IL-12p70 polarizes immune response toward pro-inflammatory Th1 phenotype, amplifies cellular inflammatory immunity, and worsens systemic inflammatory imbalance.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-5 (IL-5)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

A Th2-derived anti-inflammatory regulatory cytokine modulating eosinophil activity. Longitudinal alterations in serum IL-5 values will be evaluated using multiplex assays to assess type 2 immune regulation and inflammatory remission trend.

Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Physiological IL-5 assists immune homeostasis maintenance and antagonizes excessive pro-inflammatory responses. Dysregulated IL-5 expression disrupts overall anti-inflammatory immune compensation in the body.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
High-Density Lipoprotein Cholesterol (HDL-C)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Apolipoprotein A-I (ApoA-I) serves as its primary apolipoprotein. Longitudinal alterations in HDL-C values from baseline to each post-treatment follow-up time point will be evaluated to assess the modulation of lipid metabolism.

Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: Within the physiological range, higher concentrations are clinically desirable. Conversely, a significantly reduced level (< 1.0 mmol/L) impairs the reverse cholesterol transport pathway, leading to a corresponding increase in cardiovascular and cerebrovascular risks.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Low-Density Lipoprotein Cholesterol (LDL-C)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Its primary pathophysiological function is to transport endogenous cholesterol from the liver to peripheral arterial walls. Variations from baseline to subsequent follow-up intervals will be analyzed to evaluate the systemic lipid metabolic profile.

Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: LDL-C is established as the primary target for clinical lipid-lowering therapeutic interventions. Elevated levels accelerate cholesterol infiltration into the subendothelial space, driving atheromatous plaque formation and substantially escalating the risk of acute myocardial infarction and ischemic stroke.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Total Cholesterol (TC)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Description: TC represents the quantified sum of cholesterol contained within all circulating lipoprotein fractions. The numerical shifts between baseline and post-treatment follow-up points will be utilized to gauge the overall regulation of lipid homeostasis.

Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: TC serves as a fundamental screening biomarker for macroeconomic cardiovascular risk assessment. A longitudinal reduction in TC levels relative to baseline denotes a favorable optimization of systemic lipid metabolism and a subsequent decrease in cardiovascular risk.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Triglycerides (TG)
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52

Description: TG is derived primarily from exogenous dietary intake and endogenous hepatic synthesis. Post-treatment variations relative to baseline will be monitored across all specified follow-up time points to assess systemic lipid metabolic homeostasis.

Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: A downward shift or a stabilized reduction from baseline values reflects a clinically meaningful improvement in systemic lipid metabolic status and a mitigation of metabolic syndrome severity.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Hepatic Fibrosis (LSM)
Lasso di tempo: Baseline, week 24

Liver stiffness is assessed using ultrasound elastography. Liver stiffness measurement (LSM) reflects the degree of hepatic fibrotic remodeling.

Unit of Measure: kPa Interpretation: Higher LSM values indicate more advanced liver fibrosis.
Baseline, week 24
Hepatic Steatosis (CAP)
Lasso di tempo: Baseline, week 24

Liver fat content is assessed using ultrasound elastography. The Controlled Attenuation Parameter (CAP) reflects the degree of hepatic steatosis.

Unit of Measure: dB/m Interpretation: Higher CAP values indicate greater hepatic fat accumulation.
Baseline, week 24
Carotid Atherosclerosis Assessment: Plaque Size
Lasso di tempo: Baseline, Week 24,

High-resolution vessel wall magnetic resonance imaging (HR-VWMRI) will be utilized to perform quantitative assessments of the target vascular plaque. Longitudinal variations in plaque metrics will be analyzed by evaluating the structural changes from baseline to each post-treatment follow-up time point.

Unit of Measurement: Millimeters (mm) Clinical Significance: A statistically significant reduction in plaque dimensions relative to baseline values serves as an objective indicator of plaque regression or reversal. This morphological regression (or reduction) denotes a favorable therapeutic response, an optimization of the local vascular microenvironment, and a subsequent mitigation of the overall vascular burden.
Baseline, Week 24,
Carotid Atherosclerosis Assessment: Comparison of bilateral Carotid Intima-Media Thickness (CIMT)
Lasso di tempo: Baseline, Week 24,

Objectively evaluates macrovascular structural remodelling, atheromatous burden, and the progression or regression of systemic macrovascular sclerosis beyond isolated glycemic control.

Unit of Measurement: Millimeters (mm)
Baseline, Week 24,
Urine Albumin-to-Creatinine Ratio (UACR)
Lasso di tempo: Baseline, Week 8, Week 24
Urine albumin-to-creatinine ratio (UACR) is a sensitive marker of early renal injury and a key indicator for diabetic kidney disease screening and progression monitoring. UACR is measured from spot urine samples (first-morning void preferred). Changes in UACR from baseline reflect the impact of the intervention on renal microvascular function Unit of Measure: mg/g Interpretation: Higher UACR values indicate greater urinary albumin excretion, reflecting more advanced renal damage.
Baseline, Week 8, Week 24
Changes in Insulin Secretion during MMTT
Lasso di tempo: Baseline, Week 8, Week 52

Fasting (0 min) and 2-hour postprandial (120 min) insulin levels are measured during mixed-meal tolerance test (MMTT). Changes from baseline at various post-treatment follow-up time points are compared.

Unit of Measure: μIU/mL Interpretation: Enhanced postprandial insulin secretion indicates improved β-cell secretory function.
Baseline, Week 8, Week 52
Changes in C-peptide Levels during MMTT
Lasso di tempo: Baseline, Week 8, Week 52

Fasting (0 min) and 2-hour postprandial (120 min) C-peptide levels are measured during mixed-meal tolerance test (MMTT). Changes from baseline at various post-treatment follow-up time points are compared. C-peptide is a more stable indicator of endogenous insulin secretion than insulin itself.

Unit of Measure: ng/mL Interpretation: Increased postprandial C-peptide levels indicate preserved or improved endogenous β-cell function.
Baseline, Week 8, Week 52
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Lasso di tempo: Baseline, Week 8, Week 52

HOMA-IR is calculated from fasting blood glucose and fasting insulin (or fasting C-peptide as an alternative if patients are on an insulin regimen) to assess changes in insulin resistance from baseline to post-treatment follow-up time points.

Unit of Measure: Score on a scale (unitless) Interpretation: A lower HOMA-IR value indicates improved insulin sensitivity.
Baseline, Week 8, Week 52
Change in Homeostatic Model Assessment for β-cell Function (HOMA-β)
Lasso di tempo: Baseline, Week 8, Week 52

HOMA-β is calculated from fasting blood glucose and fasting insulin (or fasting C-peptide as an alternative if patients are on an insulin regimen) to assess changes in pancreatic β-cell function from baseline to post-treatment follow-up time points.

Unit of Measure: Percentage (%) Interpretation: A higher HOMA-β value indicates improved β-cell function.
Baseline, Week 8, Week 52
Diabetes Specific Quality of Life (DSQL)
Lasso di tempo: Baseline, Week 8, Week 52

Diabetes Specific Quality of Life Scale (DSQL) is a validated questionnaire assessing quality of life in patients with diabetes mellitus. The scale evaluates four domains: physiological function, psychological/spiritual, social relations, and treatment effects. Higher scores indicate poorer quality of life. DSQL is widely used in Chinese diabetic populations and has demonstrated good reliability and validity. The total score will be analyzed.

Unit of Measure：Score on a scale Interpretation: Higher scores indicate poorer quality of life.
Baseline, Week 8, Week 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University First Hospital

Collaboratori

ECHO Biotech

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 giugno 2026

Completamento primario (Stimato)

4 giugno 2028

Completamento dello studio (Stimato)

8 giugno 2028

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026R0184-0002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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3
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