A multicenter, open-label, single-arm study with regard to the efficacy of 10-hydroxy-cis-12-octadecenoic acid on insulin sensitivity in patients with impaired glucose tolerance and mild diabetes mellitus

JRCT ID: jRCTs051200080

Registered date:06/11/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with impaired glucose tolerance or patients with diabetes
• Date of first enrollment: 02/04/2021
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Oral administration of HYA (10-hydroxy-cis-12- octadecenoic acid)

Outcome(s)

• Primary Outcome: Changes in HOMA-IR from before HYA administration to 12 weeks after administration

Secondary Outcome

1. Changes in HOMA-IR from before HYA administration to 4 or 8 weeks after administration
2. Changes in the 75g OGTT from before HYA administration to 12 weeks after administration
3. Changes in the body weight and abdominal circumference from before HYA administration to 4 or 8, 12 weeks after administration
4. Changes in the body composition from before HYA administration to 12 weeks after administration
5. Changes in the glucose metabolism marker from before HYA administration to 4 or 8, 12 weeks after administration
6. Changes in the pancreas glucagon and active GLP-1from before HYA administration to 12 weeks after administration
7. Changes in the adipokines from before HYA administration to 12 weeks after administration
8. Changes in the liver fibrosis marker from before HYA administration to 12 weeks after administration
9. Changes in the liver function from before HYA administration to 4 or 8, 12 weeks after administration
10. Changes in the lipid from before HYA administration to 12 weeks after administration
11. Changes in the free fatty acid from before HYA administration to 4 or 8, 12 weeks after administration
12. Changes in the short chain fatty acid concentration in stool from before HYA administration to 12 weeks after administration
13. Changes in the lipid metabolite in blood from before HYA administration to 12 weeks after administration (on target analysis)
14. Changes in the lipid metabolite in stool from before HYA administration to 12 weeks after administration (on target analysis)
15. Changes in the intestinal bacterial flora from before HYA administration to 12 weeks after administration
16. Whether or not adverse events after the start of HYA administration
17. Changes in the blood pressure from before HYA administration to 4 or 8, 12 weeks after administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

1) Patients who are over 20 years and under 69 years at the time of consent acquisition (Regardless of gender)
2) Patients with BMI 25 kg/m 2 or more
3) Patients with impaired glucose tolerance and with diabetes mellitus 75 g OGTT diagnostic criteria for IGT or who do not use oral hypoglycemic drugs with HbA1c below 7.0%.
4) With regard to participation in this examination, patients who gained document consent by their own voluntary intention

Exclude criteria

1) Patients with severe hepatic dysfunction
2) Patients with severe renal dysfunction
3) Patients with cancer
4) Patients who are treated with oral or intravenous steroids
5) Patients with the medical history of cardiovascular disease
6) Pregnant women or patients who may be pregnant or breast-feeding
7) Patients who have participated in other clinical trials related to weight loss or who have taken drugs or supplements that lead to weight loss in the last 3 months.
8) Patients who lose 5% of their weight within the last 3 months
9) Patients whom clinical researchers judged to be inappropriate

Related Information

• Primary Sponsor: Ogawa Wataru
• Source(s) of Monetary Support: Noster Inc.