RIPC improves diabetic control for 15 weeks in type 2 diabetes

JRCT ID: jRCTs032210176

Registered date:01/07/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 01/10/2021
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Use of nitric oxide production equipment for 15 weeks.

Outcome(s)

• Primary Outcome: HbA1c
• Secondary Outcome: defecation frequency, Bristol Stool Form Scale, CSS(Constipation Scoring System), weight,waist circumference, hip circumference, AST, ALT, LD, ALP, gamma-GT, CK, AMY, T-BIL, D-BIL, TC, HDL-C, TG, Na, Cl, K, Ca, P, UA, BUN, Cr, TP, Alb, CRP, cystatin C, PG(plasma glucose), GA(glycoalbumin), complete blood count, urine test, urinary albumin index

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Type 2 diabetic patients who are outpatients at the Department of Endocrinology, Diabetes and Metabolism, Nippon Medical School Hospital.
2. Patients with HbA1c of 7.0% or higher at the time of enrollment despite the use of antidiabetic drugs in addition to diet and exercise therapy.
3. Patients whose HbA1c difference between immediately before and at the time of enrollment is less than or equal to +-0.25%/month.
4. Males and females aged 20 years or older at the time of obtaining consent.
5. Patients who can freely and voluntarily consent in writing to participate in the study and who can comply with this protocol.
6. Patients who do not meet the exclusion criteria.

Exclude criteria

1. Patients with type 1 diabetes mellitus.
2. Patients with recurrent severe hypoglycemia or uncontrolled hypoglycemia.
3. Patients with poorly controlled hyperthyroidism or hypothyroidism
4. Patients with severe liver disease.
5. Patients infected with hepatitis B virus or hepatitis C virus.
6. Patients with serious renal disease (e.g., renal failure), or patients with serum Cr >2.0 mg/dL or GFR <30 mL/min/1.73 m2 according to the pre-study examination.
7. Patients with serious cardiac disease or myocardial infarction within 6 months prior to study entry.
8. Patients with peripheral occlusive arterial disease or an ABI of less than 0.9.
9. Patients with venous thromboembolism.
10. Patients with serious skin disorder or infection of the lower extremities.
11. Patients with serious orthopedic disease of the lower extremities.
12. Patients with serious pancreatic disease (e.g., acute pancreatitis).
13. Patients undergoing treatment for cancer.
14. Patients with severe infections, pre- and post-surgery, and severe trauma.
15. Patients with severe diabetic neuropathy.
16. Patients with diabetic retinopathy requiring photocoagulation or vitrectomy.
17. Patients with severe ketosis, diabetic coma or precoma.
18. Patients who are heavy drinkers.
19. Pregnant women, women who may become pregnant, women who wish to become pregnant, and lactating women.
20. Elderly patients with cognitive decline or ADL decline.
21. Patients with severe obesity with a BMI of 35 kg/m2 who have not achieved significant weight loss or improvement in obesity-related health problems with medical therapy that is indicated for surgery with the primary goal of weight loss.
22. Patients who have participated in other clinical studies within 4 months prior to the start of the study.
23. Other patients who are judged to be inappropriateby the principal investigator or submitting investigator.

Related Information

• Primary Sponsor: Iwabu Masato