As there are no data on the percentage of success with the individual medications in the literature available a rough estimate based on personal experience is made. 50% will do well on acarbose 10% of the failures with acarbose will do well on…
ID
Bron
Verkorte titel
Aandoening
post gastric bypass hypoglycemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
controle of hypoglycemic episodes leading to no interference in daily life
Achtergrond van het onderzoek
Post bariatric hypoglycemia (PBH) is a frequently observed complication after bariatric surgery. The first treatment is a diet low in carbohydrates with frequent meals. a substantila number of patients will be well controled with diet alone, however there a more and more patients needing medical treatment. The medical treatment options for PBH are acarbose, diazoxide, somatostatin analogues and GLp-1 agonists. The literature on the results of these medications is limited to case reports and small cohort studies. There are currently no studies on treatment algorithms in larger cohorts. Internists involved with PBH in the Netherlands have agreed upon a treatment algorithm using stepwise acarbose, diazoxide, octreotide and finally liraglutide. The aim of this study is to prospectively document the percentage of success with the different medications using this algorithm. Patients can participate when they still have hypoglycemic complaints interfering with daily activities despite adequate dietary advice by a registered dietician with experience in post bariatric surgery patients. Data will be documented on patients charcteristics, surgery type, time to first hypoglycemic event, too of hypoglycemic documentation, frequency of hypos, quality of life (RAND36) and dumping severity (DSS).
Doel van het onderzoek
As there are no data on the percentage of success with the individual medications in the literature available a rough estimate based on personal experience is made.
50% will do well on acarbose
10% of the failures with acarbose will do well on diazoxide ( 0.1 x 0.5= 5%)
60% of failures on both will respond well to octreotide ( 0.6 x 45 = 27%)
leaving 100-50-5-27 = 18 % candidates for GLP-1 agonists
Starting with 100 patients information will be aquired with :
Acarbose : 100 pts
Diazoxide : 50 pts
Octreotide : 45 pts
GLP-1 analog : 18 pts
Onderzoeksopzet
evaluation with each medication after 3 months
Onderzoeksproduct en/of interventie
none
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- either (Roux-en-Y gastric bypass) RYGB or OAGB (mini-gastric bypass)
- documented hypoglycemia with self measured glucose (SMBG) < 3.0 mM or blinded continuous glucose monitoring (cgm) 2.8 mM
- neuroglycopenic symptoms : behavioral changes, confusion, loss of consciousness, seizures
- symptom resolution after normalization of blood glucose
- hypoglycemic episodes despite adequate dietary advice* and interfering with daily activities, socially and/or work-related
-
- willingness to participate
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- current diabetes
- Addison’s disease or glucocorticoid use
- pregnancy
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8449 |
Ander register | RTPO Leeuwarden approved as non-WMO study : RTPO 1092 |