Bariatric Surgery (Gastric Bypass)NCT02665715
Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
A study testing Low carbohydrate meals and Standard carbohydrate meals in people with Bariatric Surgery (Gastric Bypass), run by Amirsalar Samkani at 1 site in Denmark.
Trial summary
Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery (Gastric Bypass)
- What is being tested?
- Low carbohydrate meals and Standard carbohydrate meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Jun 2016
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- RYGB operated patients more than 12 month after operation
- Stable in weight for at least 3 months (+/- 3 kg)
- Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or with continuous glucose monitoring
Who cannot join
- Fasting plasma glucose concentration > 7mmol/L
- Critical illness
- Hgb < 6.5 mM
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Endocrinology Research Center, Hvidovre University Hospital
Hvidovre, Copenhagen, 2650
About this study
Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.
- Conditions
- Bariatric Surgery (Gastric Bypass)
- Being tested
- Low carbohydrate meals, Standard carbohydrate meals
- Keywords
- Reactive hypoglycemia, Hyperinsulinaemia, Diet, Glucagon-like Peptide-1, Glucagon, Peptide YY, Ghrelin
- Medical subject headings
- Hypoglycemia, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate mealsOther
Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
Standard carbohydrate mealsOther
Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate/Standard carbohydrate | Experimental | 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. Receives: Other: Low carbohydrate meals; Other: Standard carbohydrate meals |
| Standard carbohydrate/Low carbohydrate | Experimental | 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. Receives: Other: Low carbohydrate meals; Other: Standard carbohydrate meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nadir plasma glucose
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Secondary outcomes (9)
Peak plasma glucose
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Time to nadir glucose
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Time to peak glucose
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Postprandial incremental glucose area
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Postprandial decremental glucose area
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Postprandial incremental insulin area
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Postprandial incremental GLP-1 area
Between low carbohydrate meal and standard meal.
Measured: 0-240 min, 240-480 min
Time below basline glucose concentrations
Between low carbohydrate meal and standard meal.
Measured: 0-480 min
Glycemic excursions
Between low carbohydrate meal and standard meal.
Measured: 0-480 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery (Gastric Bypass)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amirsalar Samkani
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Sponsor-investigator, Amirsalar Samkani, Bispebjerg Hospital
- Investigators
- Kirstine Bojsen-Moller, MD, Postdoc, Principal investigator, Hvidovre University HospitalSten Madsbad, MD, Prof, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665715
- Sponsor's protocol ID
- DK-REAKTIV-15
- Status last verified
- Jul 2016
- First submitted
- 25 Jan 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kandel D, Bojsen-Moller KN, Svane MS, Samkani A, Astrup A, Holst JJ, Madsbad S, Krarup T. Mechanisms of action of a carbohydrate-reduced, high-protein diet in reducing the risk of postprandial hypoglycemia after Roux-en-Y gastric bypass surgery. Am J Clin Nutr. 2019 Aug 1;110(2):296-304. doi: 10.1093/ajcn/nqy310.
PubMed 30624666
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
- ClinicalTrials.gov ID
- NCT02665715
- Acronym / sponsor ID
- DK-REAKTIV-15
- Conditions
- Bariatric Surgery (Gastric Bypass)
- Keywords
- Reactive hypoglycemia, Hyperinsulinaemia, Diet, Glucagon-like Peptide-1, Glucagon, Peptide YY, Ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Amirsalar SamkaniUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate/Standard carbohydrate | Experimental | Other: Low carbohydrate meals, Other: Standard carbohydrate meals10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. |
| Standard carbohydrate/Low carbohydrate | Experimental | Other: Low carbohydrate meals, Other: Standard carbohydrate meals10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- RYGB operated patients more than 12 month after operation
- Stable in weight for at least 3 months (+/- 3 kg)
- Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or with continuous glucose monitoring
Key exclusion criteria (4 listed)
- Fasting plasma glucose concentration > 7mmol/L
- Critical illness
- Hgb < 6.5 mM
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Low carbohydrate mealsMeal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40% | Other | Low carbohydrate/Standard carbohydrate, Standard carbohydrate/Low carbohydrate |
| Standard carbohydrate mealsMeal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30% | Other | Low carbohydrate/Standard carbohydrate, Standard carbohydrate/Low carbohydrate |
Primary outcome
Nadir plasma glucose
Time frame: 0-240 min, 240-480 min
Between low carbohydrate meal and standard meal.
9 secondary outcomes
Peak plasma glucose
Time frame: 0-240 min, 240-480 min
Time to nadir glucose
Time frame: 0-240 min, 240-480 min
Time to peak glucose
Time frame: 0-240 min, 240-480 min
Postprandial incremental glucose area
Time frame: 0-240 min, 240-480 min
Postprandial decremental glucose area
Time frame: 0-240 min, 240-480 min
Postprandial incremental insulin area
Time frame: 0-240 min, 240-480 min
Postprandial incremental GLP-1 area
Time frame: 0-240 min, 240-480 min
Time below basline glucose concentrations
Time frame: 0-480 min
Glycemic excursions
Time frame: 0-480 min
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 21 Jul 2016.
- Derived from this study: PubMed 30624666Kandel D, Bojsen-Moller KN, Svane MS, Samkani A, Astrup A, Holst JJ, Madsbad S, Krarup T. Mechanisms of action of a carbohydrate-reduced, high-protein diet in reducing the risk of postprandial hypoglycemia after Roux-en-Y gastric bypass surgery. Am J Clin Nutr. 2019 Aug 1;110(2):296-304. doi: 10.1093/ajcn/nqy310.
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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.
Kirstine Bojsen-Moller, MD, Postdoc principal investigator
Hvidovre University Hospital
Sten Madsbad, MD, Prof principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate meals and Standard carbohydrate meals in people with Bariatric Surgery (Gastric Bypass), run by Amirsalar Samkani at 1 site in Denmark.
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 3 inclusion and 4 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 21 Jul 2016. 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 Denmark. 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?
Nadir plasma glucose (time frame: 0-240 min, 240-480 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665715, which also lists 1 linked publication.
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 21 Jul 2016.