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Investigation of renal protective effects of SGLT2 inhibitor by using renal doppler ultrasonography

Investigation of renal protective effects of SGLT2 inhibitor by using renal doppler ultrasonography - INveStigation of renal Protective effects of SGLT2 Inhibitor by using REnal Doppler ultrasonography/INSPIRED Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028438
Enrollment
60
Registered
2017-07-29
Start date
2017-06-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Patients, who take a 50mg of Sitagliptin at the timing of obtained agreement in this study, will be changed to take a 5mg of Dapagliflozin from Sitagliptin. The group of Sitagliptin or Dapagliflozin w

Sponsors

Ogawa Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Type 2 diabetes 2)Patients with HbA1c 7% and below 3)Patients from 20 years old but less than 80 years old at obtaining consent 4)Patients who are treated with either Dapagliflozin 5mg or Sitagliptin 50mg 5)Patients whose HbA1c is within 1% during the last 3 months 6)Patients whose medicine did not change during the last 3 months

Exclusion criteria

Exclusion criteria: 1)Type 1 diabetes or suspicion of Type 1 diabetes 2)Clinical history of hypersensitivity to SGLT2 inhibitors 3)Severe ketosis, diabetic coma or precoma 4)Severe infectious disease, pre/post-surgery or serious trauma 5)End-stage renal failure under dialysis 6)Clinical history of brain infarction or ischemic cardiac disease 7)Pulmonary embolus or severe pulmonary function impediment 8)Pituitary or adrenal gland dysfunction 9)Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia 10)Excessive alcohol intake 11)Dehydrated patients including those with non-functioning GIT such as diarrhea, vomiting or malignancy 12)Complicated with malignancies 13)Pregnant/ possible pregnant, breastfeeding 14)Inappropriate patients for study participation judged by principal or clinical investigator 15)Dosing of GLP-1 receptor agonist 16)Combined use of Dapagliflozin and Sitagliptin 17)Dosing of SGLT2 inhibitors other than Dapagliflozin 18)Dosing of DPPIV inhibitors other than Sitagliptin

Design outcomes

Primary

MeasureTime frame
Change in Resistive Index: RI of renal doppler ultrasonography

Secondary

MeasureTime frame
Group comparison of the following parameters before and after treatment 1)Physical examination Body weight, BMI, blood pressure and pulse rate 2)Hematology WBC, RBC, Hb, Ht, PLT 3)Biochemistry TC, HDL-C, TG, LDL-C, Cys-C, eGFRcyc, Cr, BUN, UA, Alb, Na, K, Cl, HbA1c, fasting blood glucose 4)plasma renin activity, plasma aldosterone concentration, erythropoietin 5)BNP 6)ketone body in venous blood 7)Urinalysis urine protein, urine Cr, urine sodium, urine potassium, urine NAG, urine alpha1-MG, urine L-FABP, urine albumin, urine glucose, urine specific gravity 8)Renal doppler ultrasonography Pulsatility Index: PI, Peak Systolic Velocity: PSV, End-Diastolic Velocity: EDV, Renal Aortic Ratio: RAR, Acceleration Time: AT 9)Abdominal ultrasonography liver 10)ABI/PWV 11)Adverse events

Countries

Japan

Contacts

Public ContactTakashi Sumita

Ogawa Red Cross Hospital Department of Internal Medicine

sumi.jp@gmail.com0493-72-2333

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026