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Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514576
Recruitment Status : Unknown
Verified July 2018 by Caroline Christfort Øhrstrøm, Zealand University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Caroline Christfort Øhrstrøm, Zealand University Hospital

Study Description
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Brief Summary:

Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia.

The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.


Condition or disease Intervention/treatment Phase
Hypoglycemia, Reactive Drug: Pasireotide 0.3 MG/ML Diagnostic Test: Meal tolerance test (MTT) Phase 4

Detailed Description:

With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to.

Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well.

The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH.

Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Pasireotide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pasireotide75
75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
 Drug: Pasireotide 0.3 MG/ML
See arm description
Other Name: Signifor

Diagnostic Test: Meal tolerance test (MTT)
Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.
Experimental: Pasireotide150
150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
 Drug: Pasireotide 0.3 MG/ML
See arm description
Other Name: Signifor

Diagnostic Test: Meal tolerance test (MTT)
Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.


Outcome Measures
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Primary Outcome Measures :
  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 ]
    Changes in incremental area under the curve (iAUC) for glucose, nadir glucose values, peak glucose values, time spent with glucose values in the hyperglycemic (>7.8 mmol/L) and the hypoglycemic (<3.9 mmol/L) range


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 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)

  2. Serum insulin levels [ Time Frame: 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)

  3. Serum C-peptide levels [ Time Frame: 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)

  4. Plasma glucagon levels [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]
    Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT)

  5. Plasma GLP-1 levels [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]
    Changes in glucagon-like peptide 1 (pmol/L) in response to a meal tolerance test (MTT)

  6. Blood pressure [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]
    Changes in blood pressure (mmHg) in response to a meal tolerance test (MTT)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RYGB operated patients with documented hypoglycemia (blood glucose <3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015)
  • Hemoglobin > 7,3 mmol/L
  • Negative human chorionic gonadotropin (hCG) urine test
  • Females of reproductive age: use of safe contraception

Exclusion Criteria:

  • Treatment for cardiovascular disease
  • Treatment with antipsychotic medication
  • Treatment for thyroid disease
  • Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
  • Prior allergic reactions to the study medicine
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514576


Locations
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Denmark
Zealand University Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Caroline C Øhrstrøm, MD Department of Medicine, Zealand University Hospital
More Information
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Responsible Party: Caroline Christfort Øhrstrøm, MD, ph.d. student, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03514576    
Other Study ID Numbers: PasHypo
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Caroline Christfort Øhrstrøm, Zealand University Hospital:
gastric bypass
hypoglycemia
hyperinsulinemia
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Pasireotide
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs