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

Phase 1

• Conditions: Postprandial reactive hypoglycemia in patients with prior Roux-en-Y gastric bypass surgery.; MedDRA version: 18.1Level: LLTClassification code 10059038Term: Postprandial hypoglycemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001086-50-DK
• Lead Sponsor: Køge Sygehus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-11
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 < 40 mmol/L, hemoglobin > 7,3, Ferritin > 10 ug/L, Cobalamin >160 pikomol/L, creatinine < 105 mmol/L, C-peptide > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
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