Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment.

NCT04332289 | Completed DMC

• 1 other identifier: DEEP1A
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (D2O) labelling experiment in patients with postprandial hyperinsulinaemic hypoglycaemia (PHH) and non-surgical non-PHH controls.

Conditions

Bariatric Surgery; Hypoglycemia; Gastric Bypass

Keywords

Insulin turnover; Insulin secretion; Deuterated Water; De-novo insulin synthesis

Outcome Measures

Primary Outcomes (1)

• Total amount of pre-stored insulin secreted

  Measured using deuterium (2H)-labelled insulin in the plasma

  During the 7 days of the heavy water administration period

Secondary Outcomes (4)

• Time course of the increase in 2H-labelled insulin in plasma

  During the 7 days of the heavy water administration period

• Time course of the increase in 2H-labelled insulin in urine

  During the 7 days of the heavy water administration period

• Time course of the increase in 2H-labelled c-peptide in plasma

  During the 7 days of the heavy water administration period

• Time course of the increase in 2H-labelled c-peptide in urine

  During the 7 days of the heavy water administration period

Study Arms (2)

PHH patients

Patients following Roux-en-Y gastric bypass surgery (≥1 year ago) with confirmed post-prandial hyperinsulinemic hypoglycemia

Other: Heavy water experiment

Healthy controls

Non-PHH, non-surgical healthy individuals

Other: Heavy water experiment

Interventions

Heavy water experiment OTHER

3 times daily heavy water (deuterated-water) and mixed meal administration for one week

Healthy controls; PHH patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• 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

Sponsors & Collaborators

• Lia Bally: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lia Bally, MD, PhD

  Bern University Hospital, 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: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: July 9, 2020
• Primary Completion: August 13, 2020
• Study Completion: August 20, 2020
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)