Bariatric SurgeryHYPOBAR1NCT03609632
Understanding Hypoglycaemia After Bariatric Surgery
A study testing Dietary Supplement: Glucose in people with Bariatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Dietary Supplement: Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Sep 2018to 2 Nov 2018
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital
Bern, 3010
About this study
Official title: Exploring Beta Cell Function in Individuals With Postbariatric Postprandial
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.
Read the detailed description
Obesity is a major global health concern that is associated with significant disability and mortality. Worldwide, the prevalence of obesity has doubled since 1980, affecting 13% of the global population. Bariatric surgery has been shown to be the most effective and durable treatment of severe obesity and leads to significant improvement of obesity-related comorbidity. However, postprandial hyperinsulinaemic hypoglycaemia (PHH) after bariatric surgery is a metabolic complication that is increasingly being recognized. Prevalence rates of up to 72% have been reported. PHH may have serious implications for affected patients, including negative effects on morbidity, mortality as well as quality of life. The pathophysiology of PPH is incompletely understood and suggests decreased adaptation of beta cell function to increased insulin sensitivity. The latter has been postulated to be largely secondary due to external factors outside the beta cells as a result of anatomical and hormonal changes after Roux-en-Y gastric bypass (RYGB). However, the intrinsic mechanistic effects of altered beta-cell function after RYGB in vivo are unknown and more exploration could lead to a better understanding of PHH pathogenesis and help identify targets for possible interventions. Previous studies performed enhanced beta cell analysis by following insulin synthesis in real-time based on stable isotope labelling of C-peptide during an oral glucose tolerance test (OGTT) in cohorts with normal and diabetic glucose tolerance. Applying the same methodological approach, albeit in a different target population (PPH after bariatric surgery), the present study seeks to explore whether or not the insulin hypersecretion can be explained by an increase in insulin synthesis, and secondly, whether potentially increased insulin synthesis can be related to other glucoregulatory hormones and measures of insulin sensitivity.
- Conditions
- Bariatric Surgery
- Being tested
- Dietary Supplement: Glucose
- Keywords
- Roux-en-Y gastric bypass (RYGB), Hypoglycaemia, Insulin, Glucose, Incretins, Stable isotope
- Medical subject headings
- Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: GlucoseOther
Intake of 75g of glucose with 1g of 13C leucine pre-feeding
| Study group | Role | What they receive |
|---|---|---|
| OGTT with 13C-labelled leucine | Experimental | Intake of 75g of glucose with 1g of 13C leucine pre-feeding Receives: Other: Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthesis rate of de novo C-peptide synthesis (%/hr)
Calculated
Measured: 4.5 hours
Secondary outcomes (9)
C-peptide levels in blood
Measured
Measured: 4.5 hours
Insulin levels in blood
Measured
Measured: 4.5 hours
Glucagon levels in blood
Measured
Measured: 4.5 hours
Incretin levels in blood
Measured
Measured: 4.5 hours
Insulin sensitivity
Calculated
Measured: 4.5 hours
Beta cell responsivity
Calculated
Measured: 4.5 hours
Hepatic insulin extraction
Calculated
Measured: 4.5 hours
C-peptide levels in urine
Measured
Measured: 4.5 hours
C-peptide enrichment
calculated
Measured: 4.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start20 Sep 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Christoph Stettler, MD, Principal investigator, Inselspital, Bern University Hospital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609632
- Sponsor's protocol ID
- HYPOBAR1
- Acronym
- HYPOBAR1
- Status last verified
- Dec 2018
- First submitted
- 25 Jul 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Beta Cell Function in Individuals With Postbariatric Postprandial
- ClinicalTrials.gov ID
- NCT03609632
- Acronym / sponsor ID
- HYPOBAR1 / HYPOBAR1
- Conditions
- Bariatric Surgery
- Keywords
- Roux-en-Y gastric bypass (RYGB), Hypoglycaemia, Insulin, Glucose, Incretins, Stable isotope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 1 Aug 2018 (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.
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.
Detailed description
Obesity is a major global health concern that is associated with significant disability and mortality. Worldwide, the prevalence of obesity has doubled since 1980, affecting 13% of the global population. Bariatric surgery has been shown to be the most effective and durable treatment of severe obesity and leads to significant improvement of obesity-related comorbidity. However, postprandial hyperinsulinaemic hypoglycaemia (PHH) after bariatric surgery is a metabolic complication that is increasingly being recognized. Prevalence rates of up to 72% have been reported. PHH may have serious implications for affected patients, including negative effects on morbidity, mortality as well as quality of life. The pathophysiology of PPH is incompletely understood and suggests decreased adaptation of beta cell function to increased insulin sensitivity. The latter has been postulated to be largely secondary due to external factors outside the beta cells as a result of anatomical and hormonal changes after Roux-en-Y gastric bypass (RYGB). However, the intrinsic mechanistic effects of altered beta-cell function after RYGB in vivo are unknown and more exploration could lead to a better understanding of PHH pathogenesis and help identify targets for possible interventions. Previous studies performed enhanced beta cell analysis by following insulin synthesis in real-time based on stable isotope labelling of C-peptide during an oral glucose tolerance test (OGTT) in cohorts with normal and diabetic glucose tolerance. Applying the same methodological approach, albeit in a different target population (PPH after bariatric surgery), the present study seeks to explore whether or not the insulin hypersecretion can be explained by an increase in insulin synthesis, and secondly, whether potentially increased insulin synthesis can be related to other glucoregulatory hormones and measures of insulin sensitivity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OGTT with 13C-labelled leucine | Experimental | Other: Dietary Supplement: GlucoseIntake of 75g of glucose with 1g of 13C leucine pre-feeding |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Dietary Supplement: GlucoseIntake of 75g of glucose with 1g of 13C leucine pre-feeding | Other | OGTT with 13C-labelled leucine |
Primary outcome
Fractional synthesis rate of de novo C-peptide synthesis (%/hr)
Time frame: 4.5 hours
Calculated
9 secondary outcomes
C-peptide levels in blood
Time frame: 4.5 hours
Insulin levels in blood
Time frame: 4.5 hours
Glucagon levels in blood
Time frame: 4.5 hours
Incretin levels in blood
Time frame: 4.5 hours
Insulin sensitivity
Time frame: 4.5 hours
Beta cell responsivity
Time frame: 4.5 hours
Hepatic insulin extraction
Time frame: 4.5 hours
C-peptide levels in urine
Time frame: 4.5 hours
C-peptide enrichment
Time frame: 4.5 hours
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 4 Dec 2018.
Related trials for Bariatric Surgery
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Recruiting
HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
RecruitingObservational study
15-years Outcomes of Sleeve Gastrectomy on Weight Loss
Bariatric Surgery, Sleeve Gastrectomy
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.
Christoph Stettler, MD principal investigator
Inselspital, 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?
A study testing Dietary Supplement: Glucose in people with Bariatric Surgery, run by Insel Gruppe AG, University Hospital Bern 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 4 inclusion and 6 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 4 Dec 2018. 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?
Fractional synthesis rate of de novo C-peptide synthesis (%/hr) (time frame: 4.5 hours). 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 4 Dec 2018.