Bariatric SurgeryDEEP1ANCT04332289
Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment.
An observational study of Bariatric Surgery and Hypoglycemia, run by Lia Bally at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Hypoglycemia, Gastric Bypass
- What is being tested?
- Heavy water experiment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jul 2020to 20 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Aged ≥18 years
- Roux-en-Y gastric bypass ≥1 year ago
- PHH defined as postprandial plasma or sensor glucose<3.0mmol/l according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia
- Aged ≥18 years
- Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Deciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia After Bariatric Surgery, Part 1 A: Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment. A Proof-of-concept Study.
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.
Read the detailed description
Despite an increased prevalence, the underlying pathophysiology of PHH remains incompletely understood. It is generally assumed that PHH is caused by excess insulin secretion, either due to an intrinsic beta-cell abnormality (histology showing increased beta-cell mass or signs of hyperfunction) and/or increased postprandial insulinotropic signals (also known as the incretin-effect) as a consequence of the re-arranged gastrointestinal tract and accelerated nutrient transit and absorption. Either of the two explanations would imply an altered insulin turnover in these patients with higher amounts of pre-stored insulin and/or accelerated de-novo insulin synthesis in response to stimulus-depletion of the available insulin pool. A non-invasive in vivo technique to study insulin turnover has not been established yet and data related to PHH are consequently lacking.
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. The investigators hypothesize that the suggested methodological approach is feasible to assess insulin turnover and provides the foundation for further studies in different target groups.
- Conditions
- Bariatric Surgery, Hypoglycemia, Gastric Bypass
- Being tested
- Heavy water experiment
- Keywords
- Insulin turnover, Insulin secretion, Deuterated Water, De-novo insulin synthesis
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy water experimentOther
3 times daily heavy water (deuterated-water) and mixed meal administration for one week
| Study group | Role | What they receive |
|---|---|---|
| PHH patients | Patients following Roux-en-Y gastric bypass surgery (≥1 year ago) with confirmed post-prandial hyperinsulinemic hypoglycemia Receives: Other: Heavy water experiment | |
| Healthy controls | Non-PHH, non-surgical healthy individuals Receives: Other: Heavy water experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of pre-stored insulin secreted
Measured using deuterium (2H)-labelled insulin in the plasma
Measured: During the 7 days of the heavy water administration period
Secondary outcomes (4)
Time course of the increase in 2H-labelled insulin in plasma
Measured: During the 7 days of the heavy water administration period
Time course of the increase in 2H-labelled insulin in urine
Measured: During the 7 days of the heavy water administration period
Time course of the increase in 2H-labelled c-peptide in plasma
Measured: During the 7 days of the heavy water administration period
Time course of the increase in 2H-labelled c-peptide in urine
Measured: During the 7 days of the heavy water administration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start9 Jul 2020
- Primary completion13 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lia Bally
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lia Bally, Insel Gruppe AG, University Hospital Bern
- Investigators
- Lia Bally, MD, PhD, Principal investigator, Bern University Hospital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332289
- Sponsor's protocol ID
- DEEP1A
- Acronym
- DEEP1A
- Status last verified
- Sep 2020
- First submitted
- 30 Mar 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia After Bariatric Surgery, Part 1 A: Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment. A Proof-of-concept Study.
- ClinicalTrials.gov ID
- NCT04332289
- Acronym / sponsor ID
- DEEP1A / DEEP1A
- Conditions
- Bariatric Surgery, Hypoglycemia, Gastric Bypass
- Keywords
- Insulin turnover, Insulin secretion, Deuterated Water, De-novo insulin synthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lia BallyUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite an increased prevalence, the underlying pathophysiology of PHH remains incompletely understood. It is generally assumed that PHH is caused by excess insulin secretion, either due to an intrinsic beta-cell abnormality (histology showing increased beta-cell mass or signs of hyperfunction) and/or increased postprandial insulinotropic signals (also known as the incretin-effect) as a consequence of the re-arranged gastrointestinal tract and accelerated nutrient transit and absorption. Either of the two explanations would imply an altered insulin turnover in these patients with higher amounts of pre-stored insulin and/or accelerated de-novo insulin synthesis in response to stimulus-depletion of the available insulin pool. A non-invasive in vivo technique to study insulin turnover has not been established yet and data related to PHH are consequently lacking.
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. The investigators hypothesize that the suggested methodological approach is feasible to assess insulin turnover and provides the foundation for further studies in different target groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHH patients | – | Other: Heavy water experimentPatients following Roux-en-Y gastric bypass surgery (≥1 year ago) with confirmed post-prandial hyperinsulinemic hypoglycemia |
| Healthy controls | – | Other: Heavy water experimentNon-PHH, non-surgical healthy individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Roux-en-Y gastric bypass ≥1 year ago
- PHH defined as postprandial plasma or sensor glucose<3.0mmol/l according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia
- Aged ≥18 years
- Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy water experiment3 times daily heavy water (deuterated-water) and mixed meal administration for one week | Other | Healthy controls, PHH patients |
Primary outcome
Total amount of pre-stored insulin secreted
Time frame: During the 7 days of the heavy water administration period
Measured using deuterium (2H)-labelled insulin in the plasma
4 secondary outcomes
Time course of the increase in 2H-labelled insulin in plasma
Time frame: During the 7 days of the heavy water administration period
Time course of the increase in 2H-labelled insulin in urine
Time frame: During the 7 days of the heavy water administration period
Time course of the increase in 2H-labelled c-peptide in plasma
Time frame: During the 7 days of the heavy water administration period
Time course of the increase in 2H-labelled c-peptide in urine
Time frame: During the 7 days of the heavy water administration period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Bally, MD, PhD principal investigator
Bern University Hospital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Hypoglycemia, run by Lia Bally at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of pre-stored insulin secreted (time frame: During the 7 days of the heavy water administration period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.