No registrations found.
ID
Source
Brief title
Health condition
post gastric bypass hypoglycemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
controle of hypoglycemic episodes leading to no interference in daily life
Secondary outcome
number of patients well controled on different medications
nember of patients with side effects on different medications
Background summary
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).
Study objective
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
Study design
evaluation with each medication after 3 months
Intervention
none
Inclusion criteria
- 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
Exclusion criteria
- current diabetes
- Addison’s disease or glucocorticoid use
- pregnancy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8449 |
| Other | RTPO Leeuwarden approved as non-WMO study : RTPO 1092 |