Cardiovascular, Renal, and Metabolic Effects of SGLT-2 Inhibitors in Type 2 Diabetes Mellitus: A Prospective Cohort Study

Q: What are the key findings of this study?

SGLT-2 inhibitor therapy reduced median urinary albumin-to-creatinine ratio from 34 to 24 mg/g (p=0.001) and mean HbA1c from 7.79% to 6.85% (p<0.001) at 6 months in patients with type 2 diabetes.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Type 2 diabetes mellitus (n=51). Intervention: SGLT-2 inhibitor therapy (empagliflozin 10 mg/day or dapagliflozin 10 mg/day) vs. Baseline (pre-treatment values; single-arm before-after comparison). Primary outcome: Spot urine albumin-to-creatinine ratio (UACR, mg/g) at 6 months compared to baseline (p=0.001).

Q: What does this research mean for the field?

SGLT-2 inhibitor therapy improves glycemic control, renal biomarkers, inflammatory markers, and echocardiographic hemodynamic indices without impairing left ventricular systolic function in patients with type 2 diabetes mellitus. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Oguzhan Karali; Ceren Gür; Irfan Sahin; Ahmet Engin Atay

doi:10.21203/rs.3.rs-11027730/v1

October 7, 2026Open Access

Cardiovascular, Renal, and Metabolic Effects of SGLT-2 Inhibitors in Type 2 Diabetes Mellitus: A Prospective Cohort Study

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Key result

SGLT-2 inhibitor therapy is linked to ~29% lower median UACR at 6 months in T2D.

P=0.001
n=51

Why the study?

Prospective real-world evidence regarding the effects of SGLT-2 inhibitors on echocardiographic parameters, pulmonary hemodynamics, and inflammatory status in patients with T2DM remains limited.

Does initiation of SGLT-2 inhibitor therapy (empagliflozin or dapagliflozin 10 mg/day) improve metabolic, renal, inflammatory, and echocardiographic parameters over 6 months in patients with type 2 diabetes mellitus?

Key Points

To assess changes in metabolic, cardiorenal, echocardiographic, and inflammatory parameters over six months of SGLT-2 inhibitor therapy in patients with type 2 diabetes mellitus.
Prospective, uncontrolled single-center cohort study of 51 patients with type 2 diabetes mellitus initiating empagliflozin (10 mg/day; 37.3%) or dapagliflozin (10 mg/day; 62.7%).
Assessed clinical, renal, hematological, and echocardiographic variables at baseline and after six months of follow-up using paired statistical analyses.
Body mass index decreased from 32.03 ± 5.35 to 30.08 ± 4.76 kg/m² (p < 0.001), systolic blood pressure dropped from 123.13 ± 11.31 to 119.51 ± 7.69 mmHg (p = 0.03), and HbA1c declined from 7.79 ± 1.32% to 6.85 ± 0.71% (p < 0.001).
Renal and inflammatory markers improved, with spot urine albumin-to-creatinine ratio dropping from 34 (21–70.5) to 24 (14–46) mg/g (p = 0.001) and C-reactive protein decreasing from 7.03 ± 4.21 to 4.25 ± 2.35 mg/L (p = 0.007).
Left ventricular ejection fraction remained stable (61.27 ± 6.62% to 62.35 ± 3.51%, p = 0.14) and TAPSE was unchanged (p = 0.10), while pulmonary artery systolic pressure increased modestly from 19.88 ± 6.34 to 21.96 ± 5.98 mmHg (p = 0.02).

Study Design

Type

Cohort (n=51)

Blinding

Single-blind

Multicenter

No

Structured PICO

Does initiation of SGLT-2 inhibitor therapy (empagliflozin or dapagliflozin 10 mg/day) improve metabolic, renal, inflammatory, and echocardiographic parameters over 6 months in patients with type 2 diabetes mellitus?

P

Population

51 adults (mean age 53.5 years, 52.9% female) with type 2 diabetes mellitus newly initiating SGLT-2 inhibitor therapy, free of NYHA class III-IV heart failure, PASP > 30 mmHg, or eGFR < 30 mL/min/1.73 m², followed for 6 months.

E

Exposure

Newly initiated SGLT-2 inhibitor therapy with oral empagliflozin 10 mg/day (37.3%) or dapagliflozin 10 mg/day (62.7%) for a fixed duration of 6 months.

O

Outcome

Changes from baseline to 6-month follow-up in clinical, metabolic, renal, inflammatory, hematological, lipid, and echocardiographic parameters (including LVEF, TAPSE, PASP, Doppler-derived indices, UACR, HbA1c, CRP, ESR, and lipid profile).surrogate

Main Result

Absolute Event Rate: 24% vs 34%

p-value: p=0.001

In a small prospective uncontrolled cohort of patients with type 2 diabetes, 6 months of SGLT-2 inhibitor therapy was associated with improvements in glycemic control, albuminuria, lipid profile, and systemic inflammatory markers while maintaining biventricular systolic function.

Limitations

Single-center study with a small sample size (N=51) and no formal sample size or power calculation
Uncontrolled, single-arm, before-after design without a concurrent comparator group, precluding causal inference
No adjustment for multiple comparisons across numerous metabolic, renal, echocardiographic, hematological, lipid, and inflammatory parameters
Effect sizes and 95% confidence intervals were not reported
Longitudinal data limited to only two time points (baseline and 6 months)
Empagliflozin and dapagliflozin users were pooled, and analyses were not adjusted for concomitant medications or clinical covariates
Exclusion of patients with advanced heart failure, elevated pulmonary pressures, or severe renal impairment limits generalizability
Pulmonary artery systolic pressure was estimated by echocardiography rather than invasive hemodynamic measurement
Uncontrolled, single-arm, before-after design without a concurrent comparator group, which precludes causal inference
Single-center study with a relatively small sample size (n=51) and no formal pre-enrollment power calculation
No statistical adjustment for multiple comparisons across numerous tested parameters, and no effect sizes or 95% confidence intervals reported
Empagliflozin and dapagliflozin users were pooled as a single group without adjustment for clinical covariates or concomitant medications
PASP was estimated echocardiographically rather than measured invasively, introducing potential measurement variability

Implication

May support real-world cardiorenal effects in type 2 diabetes; extends RCT evidence but remains hypothesis-generating and should not yet change practice.

Abstract

Background Sodium–glucose cotransporter-2 (SGLT-2) inhibitors provide cardiovascular and renal benefits in patients with type 2 diabetes mellitus (T2DM), but prospective real-world evidence regarding their effects on echocardiographic parameters, pulmonary hemodynamics, and inflammatory status remains limited. This study evaluated changes in metabolic, cardiorenal, and inflammatory parameters observed during SGLT-2 inhibitor therapy in patients with T2DM. Methods This prospective, uncontrolled single-center cohort study included 51 patients with T2DM who initiated empagliflozin (10 mg/day) or dapagliflozin (10 mg/day) and were followed for six months. Clinical, biochemical, renal, and echocardiographic parameters, including left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), pulmonary artery systolic pressure (PASP), and Doppler-derived indices, were assessed at baseline and at 6-month follow-up and compared using paired statistical tests. Results After six months, significant reductions were observed in body mass index, systolic blood pressure, heart rate, HbA1c, urinary albumin, urinary creatinine, albumin-to-creatinine ratio, inflammatory markers, and ferritin, along with improvement in lipid profile. LVEF remained stable and TAPSE was unchanged, whereas pulmonary and aortic velocity time integrals and mitral E-wave velocity increased significantly; PASP increased modestly but remained within the normal physiological range. Conclusions SGLT-2 inhibitor therapy was associated with favorable changes in metabolic control, renal biomarkers, lipid profile, and inflammatory status, without evidence of decline in left ventricular systolic function, and with favorable changes in selected echocardiographic parameters in patients with T2DM. Given the observational, uncontrolled design of this study, these findings should be regarded as hypothesis-generating rather than confirmatory; larger controlled studies are needed to confirm these associations and clarify the effects of SGLT-2 inhibitors on pulmonary hemodynamics.

Discussion

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Cite This Study

Karali et al. (2026) conducted a cohort in Type 2 diabetes mellitus (n=51). SGLT-2 inhibitor therapy (empagliflozin 10 mg/day or dapagliflozin 10 mg/day) vs. Baseline (pre-treatment values; single-arm before-after comparison) was evaluated on Spot urine albumin-to-creatinine ratio (UACR, mg/g) at 6 months compared to baseline (p=0.001). SGLT-2 inhibitor therapy reduced median urinary albumin-to-creatinine ratio from 34 to 24 mg/g (p=0.001) and mean HbA1c from 7.79% to 6.85% (p<0.001) at 6 months in patients with type 2 diabetes.

synapsesocial.com/papers/6ae682a3e432e7a5c4ef35d8 https://doi.org/10.21203/rs.3.rs-11027730/v1

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Cardiovascular, Renal, and Metabolic Effects of SGLT-2 Inhibitors in Type 2 Diabetes Mellitus: A Prospective Cohort Study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Cardiovascular, Renal, and Metabolic Effects of SGLT-2 Inhibitors in Type 2 Diabetes Mellitus: A Prospective Cohort Study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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