HypoglycemiaNCT05011682
The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery
A study testing Regular diet and 10-point nutrition plan in people with Hypoglycemia and Obesity, Morbid, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia, Obesity, Morbid
- What is being tested?
- Regular diet and 10-point nutrition plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- 27 Aug 2021to 1 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient in Nord-Trøndelag 2-4 years after Roux-en-y gastric bypass surgery
- visits Namsos outpatient clinic for follow-up.
- having at least 3 symptoms of hypoglycemia presented in the dumping severity scale (DSS).
- at least one of these symptoms must be a neuroglycopenic symptom
- all these symptoms have an intensity of 2 or 3 on DSS.
Who cannot join
- severe surgery-related complication
- revisional surgery
- life threatening health conditions.
- diabetes mellitus or other metabolic diseases
- pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Norway1 site
Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos
Namsos, Trøndelag
About this study
Official title: The Effect of Nutrition and Medical Therapy on Post-bariatric Hypoglycemia Patients 2-4 Years After a Roux-en-Y Gastric Bypass: a Pilot Study
This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.
- Conditions
- Hypoglycemia, Obesity, Morbid
- Being tested
- Regular diet, 10-point nutrition plan
- Keywords
- Gastric bypass, Diet therapy, Blood sugar variation, Quality of Life
- Medical subject headings
- Hypoglycemia, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietBehavioural
participant's usual diet during 2 weeks
10-point nutrition planBehavioural
Also called Joslin Diabetes Senter nutrition plan
controlled portions of low glycemic index carbohydrates, avoidance of rapidly absorbed carbohydrates, adjustment of timing of meals and snacks, and attention to personal and cultural barriers to implementation
| Study group | Role | What they receive |
|---|---|---|
| Joslin Diabetes Senter nutrition | Experimental | all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks) Receives: Behavioral: Regular diet; Behavioral: 10-point nutrition plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar variation
measured by continuous blood glucose monitor
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start27 Aug 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are their own controls. All participants will follow their usual diet in the first 2 weeks, and then during the next 2 weeks the 10-point nutrition plan according to Joslin Diabetes Center.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Bodil Landstad, phd, Study director, Helse Nord-Trøndelag HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011682
- Sponsor's protocol ID
- 2021/230363
- Status last verified
- Jan 2023
- First submitted
- 17 Aug 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition and Medical Therapy on Post-bariatric Hypoglycemia Patients 2-4 Years After a Roux-en-Y Gastric Bypass: a Pilot Study
- ClinicalTrials.gov ID
- NCT05011682
- Acronym / sponsor ID
- 2021/230363
- Conditions
- Hypoglycemia, Obesity, Morbid
- Keywords
- Gastric bypass, Diet therapy, Blood sugar variation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Aug 2021 (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.
This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are their own controls. All participants will follow their usual diet in the first 2 weeks, and then during the next 2 weeks the 10-point nutrition plan according to Joslin Diabetes Center.
| Arm | Type | Receives |
|---|---|---|
| Joslin Diabetes Senter nutrition | Experimental | Behavioral: Regular diet, Behavioral: 10-point nutrition planall participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient in Nord-Trøndelag 2-4 years after Roux-en-y gastric bypass surgery
- visits Namsos outpatient clinic for follow-up.
- having at least 3 symptoms of hypoglycemia presented in the dumping severity scale (DSS).
- at least one of these symptoms must be a neuroglycopenic symptom
- all these symptoms have an intensity of 2 or 3 on DSS.
Key exclusion criteria (5 listed)
- severe surgery-related complication
- revisional surgery
- life threatening health conditions.
- diabetes mellitus or other metabolic diseases
- pregnancy or breast feeding
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 |
|---|---|---|
| Regular dietparticipant's usual diet during 2 weeks | Behavioural | Joslin Diabetes Senter nutrition |
| 10-point nutrition planAlso: Joslin Diabetes Senter nutrition plancontrolled portions of low glycemic index carbohydrates, avoidance of rapidly absorbed carbohydrates, adjustment of timing of meals and snacks, and attention to personal and cultural barriers to implementation | Behavioural | Joslin Diabetes Senter nutrition |
Primary outcome
blood sugar variation
Time frame: 4 weeks
measured by continuous blood glucose monitor
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 18 Jan 2023.
- 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.
Bodil Landstad, phd study director
Helse Nord-Trøndelag HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular diet and 10-point nutrition plan in people with Hypoglycemia and Obesity, Morbid, run by Helse Nord-Trøndelag HF at 1 site in Norway.
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 5 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 18 Jan 2023. 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 Norway. 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?
blood sugar variation (time frame: 4 weeks). 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 18 Jan 2023.