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

Medical and surgical treatment of post bariatric hypoglycemia in daily practice: a retrospective observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22335

Enrollment

150

Registered

2021-05-19

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post bariatric hypoglycemia, RYGB, OAGB

Interventions

none

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
- Side effects: no, yes-acceptable, yes-not acceptable Kind of side effect Current use: yes, no-date stopped (month-year),	—

Contacts

Public ContactLoek de Heide

Medisch Centrum Leeuwarden

l.de.heide@mcl.nl0582866666

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)