Hypoglycemia, ReactivePhase 4NCT03514576
Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
A Phase 4 study testing Pasireotide 0.3 MG/ML and Meal tolerance test (MTT) in people with Hypoglycemia, Reactive, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypoglycemia, Reactive
- What is being tested?
- Pasireotide 0.3 MG/ML and Meal tolerance test (MTT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 1 Nov 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypoglycemia, Reactive
- Being tested
- Pasireotide 0.3 MG/ML, Meal tolerance test (MTT)
- Keywords
- gastric bypass, hypoglycemia, hyperinsulinemia
- Medical subject headings
- Hypoglycemia, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide 0.3 MG/MLDrug
Also called Signifor
See arm description
Meal tolerance test (MTT)Diagnostic test
Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide75 | Experimental | 75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) Receives: Drug: Pasireotide 0.3 MG/ML; Diagnostic Test: Meal tolerance test (MTT) |
| Pasireotide150 | Experimental | 150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) Receives: Drug: Pasireotide 0.3 MG/ML; Diagnostic Test: Meal tolerance test (MTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
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
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary outcomes (6)
Heart rate
Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Serum insulin levels
Changes in insulin (pmol/L) in response to a meal tolerance test (MTT)
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Serum C-peptide levels
Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT)
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Plasma glucagon levels
Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT)
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Plasma GLP-1 levels
Changes in glucagon-like peptide 1 (pmol/L) in response to a meal tolerance test (MTT)
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Blood pressure
Changes in blood pressure (mmHg) in response to a meal tolerance test (MTT)
Measured: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Jun 2018
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia, ReactiveStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Christfort Øhrstrøm, Zealand University Hospital
- Investigators
- Caroline C Øhrstrøm, MD, Principal investigator, Department of Medicine, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514576
- Sponsor's protocol ID
- PasHypo
- Status last verified
- Jul 2018
- First submitted
- 19 Apr 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT03514576
- Acronym / sponsor ID
- PasHypo
- Conditions
- Hypoglycemia, Reactive
- Keywords
- gastric bypass, hypoglycemia, hyperinsulinemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pasireotide75 | Experimental | Drug: Pasireotide 0.3 MG/ML, Diagnostic Test: Meal tolerance test (MTT)75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) |
| Pasireotide150 | Experimental | Drug: Pasireotide 0.3 MG/ML, Diagnostic Test: Meal tolerance test (MTT)150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide 0.3 MG/MLAlso: SigniforSee arm description | Drug | Pasireotide150, Pasireotide75 |
| Meal tolerance test (MTT)Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling. | Diagnostic test | Pasireotide150, Pasireotide75 |
Primary outcome
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
6 secondary outcomes
Heart rate
Time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Serum insulin levels
Time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Serum C-peptide levels
Time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Plasma glucagon levels
Time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Plasma GLP-1 levels
Time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Blood pressure
Time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline C Øhrstrøm, MD principal investigator
Department of Medicine, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pasireotide 0.3 MG/ML and Meal tolerance test (MTT) in people with Hypoglycemia, Reactive, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.