Effects of adrenalectomy on arterial hypertension, glucose and lipid metabolism in patients with mild autonomous cortisol secretion: preliminary results of a Randomized Clinical Trial

2021 ◽  
Author(s):  
Sofia Frigerio ◽  
Valentina Morelli ◽  
Carmen Aresta ◽  
Passeri Elena ◽  
Flavia Pugliese ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Metabolism ◽  
Arterial Hypertension ◽  
Randomized Clinical Trial ◽  
Cortisol Secretion ◽  
Preliminary Results ◽  
Glucose And Lipid Metabolism ◽  
Autonomous Cortisol Secretion

An open-label phase Ⅰ/Ⅱ a clinical trial of 11β-HSD1 inhibitor for Cushing’s syndrome and autonomous cortisol secretion

2021 ◽  
Author(s):  
Satoko Oda ◽  
Kenji Ashida ◽  
Makiko Uchiyama ◽  
Shohei Sakamoto ◽  
Nao Hasuzawa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Glucose Tolerance ◽  
Glucose Tolerance Test ◽  
Tolerance Test ◽  
University Hospital ◽  
Oral Glucose ◽  
Cortisol Secretion ◽  
Oral Glucose Tolerance ◽  
Open Label ◽  
Autonomous Cortisol Secretion

Abstract Context 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitors demonstrate anti-metabolic and anti-sarcopenic effects in Cushing’s syndrome (CS) and autonomous cortisol secretion (ACS) patients. Objective To confirm the efficacy and safety of S-707106 (11β-HSD1 inhibitor) administered to CS and ACS patients. Design A 24-week single-center, open-label, single-arm, dose-escalation, investigator-initiated clinical trial on a database. Setting Kyushu University Hospital, Kurume University Hospital, and related facilities. Patients Sixteen patients with inoperable or recurrent CS and ACS, with mildly impaired glucose tolerance. Intervention Oral administration of 200-mg S-707106 after dinner, daily, for 24 weeks. In patients with insufficient improvement in oral glucose tolerance test results at 12 weeks, an escalated dose of S-707106 (200-mg BID) was administered for the residual 12 weeks. Main Outcome Measures The rate of participants responding to glucose tolerance impairment, defined as those showing a 25% reduction in the area under the curve (AUC) of plasma glucose during the 75 g-oral glucose tolerance test at 24 weeks. Results S-707106 administration could not achieve the primary endpoint of this clinical trial (>20% of responsive participants). AUC glucose decreased by -7.1% (SD, 14.8 [90% CI: -14.8– -1.0], P=0.033) and -2.7% (14.5 [-10.2–3.4], P=0.18) at 12 and 24 weeks, respectively. S-707106 administration decreased AUC glucose significantly in participants with a high body mass index. Body fat percentage decreased by -2.5% (1.7 [-3.3– -1.8], P<0.001), and body muscle percentage increased by 2.4% (1.6 [1.7–3.1], P<0.001). Conclusions S-707106 is an effective insulin sensitizer and anti-sarcopenic and anti-obesity medication for these patients.

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