Treatment of Hypoglycemia Following Gastric Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-04-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery

NCT00992901

Post Bariatricsurgery Hypoglycemia

RECRUITING EARLY_PHASE1

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCT03514576

Hypoglycemia, Reactive

UNKNOWN PHASE4

Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia

NCT01865760

Obesity Hypoglycemia Surgery

COMPLETED NA

Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

NCT02665715

Bariatric Surgery (Gastric Bypass)

COMPLETED NA

Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

NCT03770637

Hyperinsulinemic Hypoglycemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. RYGB has in several studies been shown to result in significant and sustained weight loss. Moreover, RYGB has a beneficial effect on obese subjects with type 2 diabetes by improving blood glucose regulation, resulting in remission or partial remission of type 2 diabetes already days after surgery.

The changes of the anatomy of the stomach and small intestine cause a faster and more abrupt increase in blood glucose after a meal. As a consequence of the changed glucose absorption after RYGB and the increased insulin secretion, some subjects experience the condition named postprandial hyperinsulinemic hypoglycemia. Postprandial hyperinsulinemic hypoglycemia is typically seen years after RYGB and the symptoms vary from mild dizziness to confusion, loss of consciousness and seizures. The condition is characterized by large postprandial blood glucose variations accompanied by exaggerated insulin and glucagon-like peptide 1 (GLP-1) responses. Continuous glucose monitoring (CGM) have shown that subjects suffering from postprandial hyperinsulinemic hypoglycemia presents large variations in blood glucose from values below 3.5 mmol/L to diabetic values above 11.1 mmol/L within the first hour after a meal.

At present, there are no treatment guidelines beside dietary recommendations. Experimental treatment includes diet modifications, pharmaceutical treatments and surgical procedures. Several pharmaceutical agents have been attempted in the management of postprandial hyperinsulinemic hypoglycemia, but overall the existing studies consist of few case reports and case series evaluated primarily by relief of symptoms and not by CGM and hormonal analyses.

The study is designed as a randomized, non-blinded cross-over study including five treatment arms. The pharmaceutical agents are: a) Glucobay, b) Januvia, c) Verapamil, d) Victoza and e) Signifor. The treatment duration is 1 - 3 weeks, except for Signifor, which is administered for one day only. Each treatment period is separated by a wash out period of 7-10 days.

Sixteen none diabetic women are included in the study. They have undergone RYGB and have symptoms of postprandial hyperinsulinemic hypoglycemia. Moreover, former CGM has shown fluctuations in blood glucose of more than 5 mmol/L during daily living and with at least one blood glucose reading below 3.5 mmol/L.

Six days continuous glucose monitoring will be performed at run-in and during each treatment arm, except for e) Signifor due to the short treatment period. At the end of the CGM measurement a meal tolerance test (MTT) will be performed. During the MTT blood samples for glucose measurements and hormone assessments (insulin, C-peptide, GLP-1, gastric inhibitory peptide (GIP), glucagon, insulin like growth factor (IGF-1), epinephrine, norepinephrine) will be drawn continuously as well as continuous pulse recording and blood pressure measurements.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoglycemia Obesity Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

glucobay Januvia Verapamil HEXAL Victoza Signifor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No