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Delfa

← All trials/NCT02527993

CompletedPhase 4

Treatment of Hypoglycemia Following Gastric Bypass Surgery

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

-

Actual enrollment

11

Study population

Bariatric Surgery

Eligibility highlights

•Female

Primary endpoint

•Changes in blood glucose (mmol/L)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02527993
Org study IDHypoGB2015

Timeline

Milestones

Study first posted2015-08-19estimated
Primary completion2017-04-08actual
Study completion2017-04-08actual
Last update posted2018-03-07actual
Study start2015-10 (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Bariatric Surgery

Who can enroll

Minimum age25 Years
Maximum age60 Years
SexFemale
Healthy volunteersNot 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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Glycemic / diabetes
4
Cardiometabolic biomarkers
1

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint/low confidence

Changes in blood glucose (mmol/L) assessed by continuous glucose monitoring (CGM).

Time frame:6 days CGM will be performed at week 1, 3, 5, 7 and 11.

descriptive

Secondary/protocol endpoint

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.

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in insulin (pmol/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.

change from baseline, improvement

Secondary/protocol endpoint

Changes in C-peptide (nmol/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.

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)

Time frame:From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion.

Heart rate, change

change from baseline, improvement

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Changes in Insulin-like growth factor 1 (nmol/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.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in glucagon (pmol/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.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in glucagon-like peptide 1 (pmol/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.

descriptive

Secondary/protocol endpoint/low confidence

Changes in gastric inhibitory peptide (pmol/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.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in epinephrine (pmol/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.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in norepinephrine (pmol/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.

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.