Treatment of blood sugar variations in patients with prior gastric bypass surgery

Treatment of hypoglycemia following gastric bypass surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001086-50-DK

Enrollment

Unknown

Registered

2015-05-11

Start date

2015-06-03

Completion date

Unknown

Last updated

2017-06-05

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

Conditions

Postprandial reactive hypoglycemia in patients with prior Roux-en-Y gastric bypass surgery. MedDRA version: 18.1 Level: LLT Classification code 10059038 Term: Postprandial hypoglycemia System Organ Class: 100000004861

Interventions

Trade Name: Glucobay Pharmaceutical Form: Tablet INN or Proposed INN: ACARBOSE CAS Number: 56180-94-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Roux-en-Y gastric bypass surgery more than 18 months ago. Symptoms corresponding with Whipples Triad. 5 days continuous glucose monitoring showing variations in interstitial glucose > 5,5, mmol/L No prior history of diabetes HbA1c 7,3, Ferritin > 10 ug/L, Cobalamin >160 pikomol/L, creatinine 1,0 nmol/L, Insulin > 35 pmol/L, normal electrocardiogram, negative urine-hCG 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 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Treatment of cardiovascular disease Treatment with anxiolytic or antipsychotic medicine Treatment with tricyclic antidepressants. Other antidepressant treatment is acceptable if there has been no changes to the dose within 3 months prior to study participation. Smoking Treatment of either hypo- og hyperthyroidism Prior medical treatment for postprandial hypoglycemia Allergy for any of the active substances in the trial medicine

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effects of 5 different pharmacological treatments on glucosemetabolism in patients with postprandial hypoglycemia following gastric bypass surgery. ;Secondary Objective: To describe the changes in hormones and in the autonomic nervous system during hypoglycemia. ;Primary end point(s): Changes in glucosevariations assessed by continuous glucose monitoring. ;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: To study the effects of 5 different pharmacological treatments on glucosemetabolism in patients with postprandial hypoglycemia following gastric bypass surgery. ;Secondary Objective: To describe the changes in hormones and in the autonomic nervous system during hypoglycemia. ;Primary end point(s): Changes in glucosevariations assessed by continuous glucose monitoring. ;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): Changes i hormones and vital signs measured during a mixed meal tolerance test;Timepoint(s) of evaluation of this end point: End of trial	—

Countries

Denmark

Contacts

Public ContactCaroline Christfort Gormsen

Køge Sygehus

cacg@regionsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026