Treatment of Hypoglycemia Following Gastric Bypass Surgery
1 other identifier
interventional
11
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2017
CompletedMarch 7, 2018
March 1, 2018
1.5 years
August 11, 2015
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in blood glucose (mmol/L) assessed by continuous glucose monitoring (CGM).
6 days CGM will be performed at week 1, 3, 5, 7 and 11.
Secondary Outcomes (10)
Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.
Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.
Changes in insulin (pmol/L) in response to a meal tolerance test (MTT)
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.
Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT)
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.
Changes in Insulin-like growth factor 1 (nmol/L) in response to a meal tolerance test (MTT)
From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.
- +5 more secondary outcomes
Study Arms (5)
Glucobay
EXPERIMENTALTablet Glucobay (acarbose) 50 mg x 6 daily for 7 days.
Januvia
EXPERIMENTALTablet Januvia (sitagliptin) 100 mg orally O.D for 7 days.
Verapamil
EXPERIMENTALTablet Verapamil 120 mg orally O.D for 7 days.
Victoza
EXPERIMENTALSubcutaneous injection of Victoza (liraglutide) 0,6-1,2 mg O.D for three weeks.
Signifor
EXPERIMENTALSubcutaneous injection of Signifor (pasireotide) 300 µg as a single dose prior to a meal tolerance test.
Interventions
Continuous glucose monitoring will be performed during 6 days of the treatment period.
A meal tolerance test will be performed at the end of the treatment period. The subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ohrstrom CC, Worm D, Kielgast UL, Holst JJ, Hansen DL. Evidence for Relationship Between Early Dumping and Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass. Obes Surg. 2020 Mar;30(3):1038-1045. doi: 10.1007/s11695-020-04387-6.
PMID: 31907828DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline C Gormsen, M.D.
Department of Internal Medicine, Koege University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, clinical assistant
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 19, 2015
Study Start
October 1, 2015
Primary Completion
April 8, 2017
Study Completion
April 8, 2017
Last Updated
March 7, 2018
Record last verified: 2018-03