NCT03609632

Brief Summary

Postprandial hyperinsulinaemic hypoglycaemia is an increasingly recognized adverse side effect of bariatric surgery. Affected individuals experience low glucose levels 1-3 hours after intake of meals, accompanied by symptoms such as drowsiness, sweating, hunger and palpitations. Hypoglycaemia can be serious and have potential dangerous health impact (e.g. road accident or fall due to loss of consciousness). The pathophysiology is incompletely understood and more research is needed in search of preventive and therapeutic strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

July 25, 2018

Last Update Submit

December 3, 2018

Conditions

Bariatric Surgery

Keywords

Roux-en-Y gastric bypass (RYGB)HypoglycaemiaInsulinGlucoseIncretinsStable isotope

Outcome Measures

Primary Outcomes (1)

  • Fractional synthesis rate of de novo C-peptide synthesis (%/hr)

    Calculated

    4.5 hours

Secondary Outcomes (9)

  • C-peptide levels in blood

    4.5 hours

  • Insulin levels in blood

    4.5 hours

  • Glucagon levels in blood

    4.5 hours

  • Incretin levels in blood

    4.5 hours

  • Insulin sensitivity

    4.5 hours

  • +4 more secondary outcomes

Study Arms (1)

OGTT with 13C-labelled leucine

EXPERIMENTAL

Intake of 75g of glucose with 1g of 13C leucine pre-feeding

Other: Dietary Supplement: Glucose

Interventions

Dietary Supplement: GlucoseOTHER

Intake of 75g of glucose with 1g of 13C leucine pre-feeding

OGTT with 13C-labelled leucine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric bypass (RYGB) surgery performed ≥ 6 months ago
  • Confirmed postprandial hypoglycaemia (continuous glucose monitoring or plasma glucose), with at least 2 episodes of Whipple's triad (symptoms, capillary of interstitial glucose ≤3.1mmol/L, symptom resolution by carbohydrate intake) ≤3 months ago
  • Normal glucose control at recruitment and absence of (pre)diabetes before bariatric surgery
  • Capacity to give informed consent

You may not qualify if:

  • Fasting hypoglycaemia suggesting hyperinsulinism of different aetiology
  • Use of medication that influence glucose metabolism
  • Bariatric procedures other than RYGB
  • Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
  • Moderate to severe chronic kidney disease
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

HypoglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Christoph Stettler, MD

    Inselspital, Bern University Hospital, University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

September 20, 2018

Primary Completion

November 2, 2018

Study Completion

November 2, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

CH(1)