PBH-MASTER study: Post Bariatric Hypoglycemia Medical And Surgical Treatment Evaluation in Retrospect study

Recruiting

Conditions: post bariatric hypoglycemia, RYGB, OAGB

Registration Number: NL-OMON22335

Lead Sponsor: Medical Center Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

(Roux-en-Y gastric bypass) RYGB or OAGB (mini-gastric bypass)
-documented hypoglycemia with self-measured glucose (SMBG) < 3.0 mM, blinded continuous glucose monitoring (cgm) 2.8 mM or Meal Test ( < 3.0 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

-diabetes or use of diabetic medication when medical treatment of PBH was started
-Addison’s disease or glucocorticoid use
-pregnancy

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Number of drugs currently used for PBH: 1, 2, 3, more<br>Then for each drug: <br>-Name of drug<br>-Number in line of treatment: first, second, third, etc.<br>-Replacement or addition<br>-Daily total dosage used<br>-Start date (month-year)<br>-Treatment effect: <br>objective : 1. resolution of severe hypoglycemia (neuroglycopenia or glucose (SMBG) < 3.0 mM or blinded continuous glucose monitoring (cgm) 2.8 mM), >50% resolution, < 50% resolution, 0-20% resolution <br> 2. number of hypoglycemic events per week/month for which action is needed<br>subjective :1. As documented in the file: semi-quantitive: <br>complete resolution, near-complete, acceptable decrease, not enough decrease, no decrease in hypo-episodes<br> 2. Patient questionnaire: see questionnaire<br><br>

Secondary Outcome Measures