Empaglifozin in patients with hypoglycaemia after meal after bariatric surgery - a pilot study

Phase 1

• Conditions: Postprandial hyperinsulinemic hypoglycaemia (PHH) typically occurs years after bariatric surgery and one to three hours after a carbohydrate-rich meal. It is caused by rapid gastric emptying of undigested carbohydrates leading to high plasma glucose concentrations and increased incretin release which results in hyperinsulinemia and finally hypoglycaemia. Patients may suffer from fatigue, weakness, confusion, hunger, syncope, perspiration, palpitations or tremor.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-006127-34-AT
• Lead Sponsor: Verein zur Förderung der Wissenschaft und Forschung an der 1.Med. Abteilung der Krankenanstalt Rudolfstiftung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-09
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

>= 18 years, <=65 years, no diagnosis of type 2 diabetes mellitus, Time of bariatric surgery > 1 year, No reported hypoglycemic episodes before bariatric surgery, Symptoms of PHH after bariatric surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

diabetes mellitus type 1, type 2 or HbA1c = 6.5% or use anti-diabetic drugs or insulin, Use of any drug to treat PHH in the last four weeks (acarbose etc.), Have a current infection, anamnestic necrotising fasciitis, Follow a ketogenic diet, impaired renal function with a eGFR = 60 ml/min/m², recurrent urinary tract infections (= 2 episodes during the last year), pyelonephritis (=1 episode during the last 5 years), urosepsis (=1 episode during the last 5 years), Known or suspected hypersensitivity to trial product(s) or related products, Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method, Have diagnosed insulinoma, Had reoperation or revision of bariatric surgery , severe gastroparesis, BMI = 18.5 kg/m², severe cardiovascular disease with any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 90 days prior to the day of screening, Subjects presently classified as being in New York Heart Association Class IV, Have acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine transaminase (ALT) level =3.0 above the upper limit of normal (ULN) for the reference range, as determined by the central laboratory, Have a history of an active or untreated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years, Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol, Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study, Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer), should have passed

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified