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Trial · Interventional

CompletedPhase 4Registry data

Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCTNCT02527993 (opens ClinicalTrials.gov in a new tab)Other idHypoGB2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
11 participants (actual)
Sponsor
Zealand University Hospital · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Oct 2015
Primary completion
8 Apr 2017
Completion
8 Apr 2017
First posted
19 Aug 2015 (estimated)
Last update posted
7 Mar 2018
Conditions
Hypoglycemia · Obesity · Surgery

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    Treatment of Hypoglycemia Following Gastric Bypass Surgery

    NCT02527993

    Oct 2015 to 8 Apr 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation. However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations. The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.

Interventions

  • Glucobay (acarbose)Drug
  • Januvia (sitagliptin)Drug
  • Verapamil HEXAL (verapamil)Drug
  • Victoza (liraglutide)Drug
  • Signifor (pasireotide)Drug
  • Continuous glucose monitoring (CGM)Device
  • Meal tolerance test (MTT)Dietary supplement

Arms5

  • Experimental

    Glucobay

    Tablet Glucobay (acarbose) 50 mg x 6 daily for 7 days.

  • Experimental

    Januvia

    Tablet Januvia (sitagliptin) 100 mg orally O.D for 7 days.

  • Experimental

    Verapamil

    Tablet Verapamil 120 mg orally O.D for 7 days.

  • Experimental

    Victoza

    Subcutaneous injection of Victoza (liraglutide) 0,6-1,2 mg O.D for three weeks.

  • Experimental

    Signifor

    Subcutaneous injection of Signifor (pasireotide) 300 µg as a single dose prior to a meal tolerance test.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in blood glucose (mmol/L) assessed by continuous glucose monitoring (CGM).

    Time frame · 6 days CGM will be performed at week 1, 3, 5, 7 and 11.

Secondary outcomes(10)

  1. Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  2. Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  3. Changes in insulin (pmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  4. Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  5. Changes in Insulin-like growth factor 1 (nmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  6. Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  7. Changes in glucagon-like peptide 1 (pmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  8. Changes in gastric inhibitory peptide (pmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  9. Changes in epinephrine (pmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

  10. Changes in norepinephrine (pmol/L) in response to a meal tolerance test (MTT)

    Time frame · From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2020

Evidence for Relationship Between Early Dumping and Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass.

Øhrstrøm et al. 2020Obesity surgerycited by 12

PMID 31907828DOI 10.1007/s11695-020-04387-6PUB-31907828

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 25 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * symptoms of postprandial hyperinsulinemic hypoglycemia. * fluctuations in blood glucose of more than 5 mmol/L during daily living * at least one blood glucose reading below 3.5 mmol/L. * More than 18 months since RYGB * HbA1c \< 40 mmol/L * Hemoglobin \> 7,3 mmol/L * Ferritin \> 30 µg/L * Cobalamin \> 150 picomol/L * Creatinine \< 105 mmol/L * C peptide \> 1,0 nmol/L * Insulin \> 35 pmol/L * Normal EKG * Negative human chorionic gonadotropin (hCG) urine test * Females of reproductive age: use of safe contraception Exclusion Criteria: * Treatment for cardiovascular disease * Treatment with antipsychotics, antidepressants or anxiolytics * Smoking * Treatment for thyroid disease * Prior medical treatment of postprandial hyperinsulinemic hypoglycemia * Allergy for the study medicine

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