NCT04334161

Brief Summary

The primary objective of this study is to assess the neuro-endocrine response to hypoglycaemia in PHH vs. non-PHH post-gastric bypass individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

March 30, 2020

Last Update Submit

August 9, 2021

Conditions

Roux-en-y Gastric BypassPost Prandial Hypoglycemia

Keywords

Counter-regulation to hypoglycemiaNeuro-endocrine responseGlucagon

Outcome Measures

Primary Outcomes (1)

  • Glucagon response during the 20min hypoglycaemic period as defined using the area under the concentration curve (AUC)

    20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)

Secondary Outcomes (10)

  • Response of C-peptide during the 20min hypoglycaemic period as determined by the area under the curve (AUC).

    20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)

  • Response of cortisol during the 20min hypoglycaemic period as determined by the area under the curve (AUC).

    20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)

  • Response of adrenaline during the 20min hypoglycaemic period as determined by the area under the curve (AUC).

    20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)

  • Response of noradrenaline during the 20min hypoglycaemic period as determined by the area under the curve (AUC).

    20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)

  • Response of growth hormone during the 20min hypoglycaemic period as determined by the area under the curve (AUC).

    20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)

  • +5 more secondary outcomes

Other Outcomes (23)

  • Time course of the hormonal response during the whole experiment.

    From the start of the experiment (100 minutes before the oral glucose load) until the end of the experiment (170 minutes after the oral glucose load)

  • Time course of rate of glucose appearance (Ra total) during the whole experiment

    From the start of the experiment (100 minutes before the oral glucose load) until the end of the experiment (170 minutes after the oral glucose load)

  • Time course of rate of glucose disappearance (Rd) during the whole experiment

    From the start of the experiment (100 minutes before the oral glucose load) until the end of the experiment (170 minutes after the oral glucose load)

  • +20 more other outcomes

Study Arms (4)

PHH patients

Patients with Roux-en-Y gastric bypass ≥1 year ago and confirmed postprandial hyperglycaemic hypoglycaemia (PHH). PHH is defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia

Combination Product: Administration of glucose and controlled induction of hypoglycaemia.

non-PHH gastric bypass patients

Patients with Roux-en-Y gastric bypass ≥1 year ago without evidence of PHH.

Combination Product: Administration of glucose and controlled induction of hypoglycaemia.

non-PHH sleeve gastrectomy patients

Patients with sleeve gastrectomy ≥1 year ago without evidence PHH.

Combination Product: Administration of glucose and controlled induction of hypoglycaemia.

non-PHH non-surgical controls

Absence of any conditions or previous surgery known to affect gastro-intestinal integrity and food absorption.

Combination Product: Administration of glucose and controlled induction of hypoglycaemia.

Interventions

Administration of glucose and controlled induction of hypoglycaemia.COMBINATION_PRODUCT

Functional metabolic test involving a 15g oral glucose load (enriched with 1.5% U-13C glucose) and subsequent controlled 20min hypoglycaemic clamp period. Neuroendocrine response will be assessed using frequent blood samples for hormones and metabolites, continuous heart rate monitoring and evaluation for hypoglycaemic symptoms.

PHH patientsnon-PHH gastric bypass patientsnon-PHH non-surgical controlsnon-PHH sleeve gastrectomy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited by referral from our outpatient endocrine clinic and collaborating Centres of Excellence for Metabolic Surgery. Non-surgical controls will be recruited through advertisement according to guidelines from swissethics.

You may qualify if:

  • Aged ≥18 years
  • Roux-en-Y gastric bypass ≥1 year ago
  • Aged ≥18 years
  • Roux-en-Y gastric bypass (Group 2) or sleeve gastrectomy (Group 3) ≥1 year ago
  • No evidence of PHH
  • Aged ≥18 years
  • Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption

You may not qualify if:

  • Clinically relevant weight changes (≥5%) within the past 3 months
  • Incapacity to give informant consent
  • Historical or current diabetes based on HbA1c ≥6.5% without glucose-lowering treatment
  • Haemoglobin level below 13.5 g/l
  • Ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility
  • Active heart, lung, liver, gastrointestinal, renal or neurological disease
  • Inability to follow study procedures
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Tripyla A, Herzig D, Reverter-Branchat G, Pavan J, Schiavon M, Eugster PJ, Grouzmann E, Nakas CT, Sauvinet V, Meiller L, Zehetner J, Giachino D, Nett P, Gawinecka J, Del Favero S, Thomas A, Thevis M, Dalla Man C, Bally L. Counter-regulatory responses to postprandial hypoglycaemia in patients with post-bariatric hypoglycaemia vs surgical and non-surgical control individuals. Diabetologia. 2023 Apr;66(4):741-753. doi: 10.1007/s00125-022-05861-9. Epub 2023 Jan 17.

    PMID: 36648553DERIVED

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lia Bally, MD, PhD

    University Hospital Bern & University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 6, 2020

Study Start

October 2, 2020

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)