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NCT03514576·Phase 4·INTERVENTIONAL

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

PasireotideOtherUnknown

Status

Unknown

Phase

Phase 4

Enrollment

5

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Pasireotide 0.3 MG/ML

See arm description

DIAGNOSTIC_TEST

Meal tolerance test (MTT)

Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Timeline

From registration to results.

  1. First posted

    May 2, 2018

  2. Study start

    Jun 1, 2018

  3. Primary completion

    Aug 1, 2018

  4. Study completion

    Nov 1, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jul 5, 2018

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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)

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)

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)

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)

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)

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

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Zealand University Hospital

Køge, Denmark

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Pasireotide.

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