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The Effect of Peripheral Ischemia-Reperfusion Stimulation on Improving Glucose Tolerance in Type 2 Diabetes Patients Receiving aNtidiabetic Drugs or Basal Insulin Replacement Therapy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	type 2 diabetes mellitus
Date of first enrollment	10/02/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Remote Ischemic Preconditioning will be performed. Using a test device (NO generating device), a thigh compression program (5 minutes of avascularization followed by 3 minutes of compression release, repeated 3 times) will be performed once a day for 8 weeks. The compression pressure will be 75% of systolic blood pressure.

Outcome(s)

Primary Outcome

Change from baseline in interstitial fluid glucose concentration measured by isCGM at 6 weeks after the start of RIPC

Secondary Outcome

(1) Change from baseline in interstitial fluid glucose concentration measured by isCGM at 2 weeks after the start of RIPC. (2) Differences in changes from baseline in interstitial fluid glucose concentration measured by isCGM at 2 weeks and 6 weeks between the RIPC and non-RIPC groups. (3) Changes over time in interstitial fluid glucose concentration measured by isCGM in the RIPC group: daily maximum and minimum values, time in range (TIR)(70-180 mg/dL), time above range (TAR)(>180 mg/dL), and time below range (TBR)(<70 mg/dL). (4) Changes from baseline in blood glucose levels measured by blood sampling at 4 weeks and 8 weeks after the start of RIPC, and the difference between the changes over the same period in the non-RIPC group. (5) Standard deviation (SD), coefficient of variation (SV), and mean amplitude of variation (MAGE) of interstitial fluid glucose concentration measured by isCGM at 2 weeks and 6 weeks after the start of RIPC. Changes from baseline in glycemic excursion, AUC (Area Under the Curve) > 180, and AOC (Area Over the Curve) < 70, and the difference from the change during the same period in the non-RIPC group. (6) Changes from baseline in glycated albumin at 8 weeks after the start of RIPC. (7) Changes from baseline in laboratory test values (hematology, blood chemistry, and urinalysis) at 8 weeks after the start of RIPC, and the difference from the change during the same period in the non-RIPC group. (8) Changes in interstitial fluid glucose concentration over time in the assigned group: baseline at the first half of the treatment period, at 2 weeks, 6 weeks, and at baseline during the second half of the treatment period. (9) Changes in blood glucose levels obtained by blood sampling over time in the assigned group: baseline at the first half of the treatment period, at 4 weeks, 8 weeks, and at baseline during the second half of the treatment period. (Exploratory) Changes in interstitial fluid glucose concentration and blood glucose levels stratified by the presence or absence of insulin administration.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Outpatients with type 2 diabetes (2) Patients currently undergoing dietary and exercise therapy and taking antidiabetic medications (excluding insulin) or/and patients receiving long-acting insulin up to once per day for basal insulin replacement therapy (3) Patients with an HbA1c level of 7.0% or higher at the time of screening (4) Patients whose HbA1c levels within the three months prior to consent acquisition differ by + or - 0.25%/month or less from the HbA1c levels at the time of the study screening (5) Patients aged 20 years or older at the time of consent acquisition (6) Patients who are able to voluntarily consent to participate in the study and who are able to comply with this protocol.
Exclude criteria	(1) Type 1 diabetes patients (including those with concomitant diabetes) (2) Patients requiring insulin treatment more frequently than once a day (3) Patients with serious heart disease or a history of myocardial infarction within six months prior to obtaining consent (4) Patients with lower limb arterial occlusive disease or venous thromboembolism or a history of these conditions (5) Patients with serious infections, especially those of the lower limbs, or skin disorders (6) Patients with serious orthopedic diseases of the lower limbs (e.g., femoral head necrosis) (7) Patients with serious pancreatic diseases (e.g., acute pancreatitis) (8) Patients undergoing treatment for malignant neoplasms (9) Patients with severe diabetic complications (neuropathy, retinopathy, etc., kidney or liver damage) (10) Pregnant women or women who may be pregnant (11) Patients diagnosed with dementia (12) Patients who use medical devices (implantable medical devices, etc.) other than those used in the study, such as pacemakers, whose use cannot be stopped (13) Other individuals who are deemed inappropriate by the principal investigator or co-investigator.