Effect of dapagliflozin, the sodium-glucose-cotransporter-2 (SGLT2) inhibitor, on fibroblast growth factor 21 (FGF21), a novel hepatokine and myokine, in Japanese patients of type 2 diabetes

Phase 4

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000021479
• Lead Sponsor: ational Hospital Organization Kyoto Medical Center

Brief Summary

Bodyweight decreased in the dapagliflozin group, but the changes in SMM were not significant between the groups, thereby elevating the ratio of SMM-to-bodyweight in the dapagliflozin group. Myostatin levels were significantly decreased, and irisin levels showed a nearly significant reduction in the dapagliflozin group compared with the control group, whereas FGF21 levels did not change significantly from baseline to the end of the intervention in both groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Study Completion: 2018-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1.Subjects with secondary obesity associated with endocrine disorders 2.Type 1 diabetes mellitus 3.Subjects with severe ketosis, diabetic coma or precoma 4.Subjects with severe infection, before and after surgery or severe injury 5.Subjects with severe hepatic dysfunction 6.Subjects with moderate or more of renal dysfunction (serum creatinine >= 1.5mg/dl[male], 1.3mg/dl[female]). 7.The subjects within the past 6 months, developed stroke, myocardial infarction, or other serious vascular complications requiring hospitalization 8.Subjects with dehydration, diarrhea, vomiting or gastrointestinal injury 9.Subjects in SGLT-2 inhibitors, insulin formulation, GLP-1 receptor agonist prescription 10.Subjects in TZD, fibrate prescription 11.Subjects in pregnant women, lactating women, the potential or planned are pregnant 12.Subjects with a history of hypersensitivity to SGLT-2 inhibitor 13.Subjects who have been determined to be unsuitable for the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum FGF21 level (At 0, 12 and 24 weeks after administration)

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose, body weight, waist circumference, blood pressures, visceral fat mass, subcutaneous fat mass, CAVI, leptin, adiponectin, hs-CRP, muscle thickness of six sites of the body using B-mode ultrasound, skeletal muscle mass, % fat, total body water weight ratio, lean body mass, basal metabolic rate, and serum other miokines (myostatin, irisin, IL-6)