Obesity, MorbidBut2NCT05767177
Jejunal Ketogenesis and Type 2 Diabetes
A study testing Glucemia following Mixed Meal Test and Enteroscopy - mucosal ketogenic activity as well as glucose transport in people with Obesity, Morbid and Diabetes Mellitus, Type 2, run by Göteborg University at 1 site in Sweden.
Trial summary
The goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Diabetes Mellitus, Type 2, Intestines
- What is being tested?
- Glucemia following Mixed Meal Test and Enteroscopy - mucosal ketogenic activity as well as glucose transport
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2023to 22 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 35 to 45 kg/m2
Who cannot join
- Insulin-treated diabetes
- Sequelae of previous diabetes-associated disease (foot, eyes and kidneys, or cardiovascular incident, etc.)
- Diabetes, hypertension, lipid disorder that has not been stabilized for at least 1 month by adequate pharmacological treatment
- Continuous NSAID use
- Preferably otherwise medication-free (exceptions can be made)
- Not operated on in the abdomen (appendectomy excluded)
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- Previously known organic gastrointestinal disease, except for gastroesophageal reflux disease (GERD)
- Smokers
- Pregnancy and breastfeeding
- History of drug abuse or other circumstances deemed to jeopardize the patient's ability to participate in the research project
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Surgery, Sahlgrenska Universityhospital
Gothenburg, SE41345
About this study
Official title: Small Intestinal Ketogenesis - Potential Significance for Type 2 Diabetes in Obesity
The goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
Read the detailed description
The investigators have recently shown that the mucosa in the middle small intestine, the jejunum, in human volunteers produce ketones bodies.This situation is thus contrary to the common view that ketone bodies are formed by the liver during fasting/starvation. Obesity is commonly associated with hyperglycaemic conditions and diabetes mellitus type 2.This has given rise to the question of whether obesity results in disturbances in the intestinal food-induced ketogenesis and whether this influence contributes to the development of type 2 diabetes mellitus?
The project's questions are therefore:
- Does food intake-induced ketogenesis exist in the small intestine of obese individuals?
- Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
- If no to 2: What is the difference?
- Conditions
- Obesity, Morbid, Diabetes Mellitus, Type 2, Intestines, Incretins
- Being tested
- Glucemia following Mixed Meal Test, Enteroscopy - mucosal ketogenic activity as well as glucose transport
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucemia following Mixed Meal TestOther
On day 12 of each diet, a venous catheter is placed in one arm for blood sampling and the research person must answer questions about any gastrointestinal complaints in connection with the current diet. At approximately 09:00, the research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal). Venous blood samples are taken before and 15, 30, 45, 60, 90 and 120 minutes after the meal.
Enteroscopy - mucosal ketogenic activity as well as glucose transportOther
On day 14 of each diet period, an enteroscopy is performed. This step is performed to obtain samples (biopsy) of the mucosa of the small intestine (duodenum and jejunum) and is performed at the Gastro-endoscopic departments SU-Sahlgrenska, or SU-Eastern hospital. Endoscopy is experienced by some individuals as unpleasant, which is why local anesthesia and sometimes sedation (midazolam + pethidine or rapifen) can be offered according to standard routine in the endoscopy department.
| Study group | Role | What they receive |
|---|---|---|
| High Carbohydrate Diet vs High Fat Diet | Experimental | In the current project, the situation applies to individuals with obesity (body mass index (BMI) 35 to 45 kg/m2). In one case the diet is of the type "high-carbohydrate diet" and in the other case "high-fat diet". The idea is that the research subjects should subsist on these diets for the respective 14 days. The energy content of the diet periods must be the same and correspond to the participants' daily needs. Each participant is drawn to one diet for 2 weeks. After a break of at least 3 weeks, the second diet is taken for 2 weeks. Receives: Other: Glucemia following Mixed Meal Test; Other: Enteroscopy - mucosal ketogenic activity as well as glucose transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucemia following a Mixed Meal Test:
The study participant arrives fasted and a venous catheter is placed in one arm for blood sampling. The research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal) and the p-glucose (mM) is checked at 120 min.
The glucemia after the test meal will be compared in high-carbohydrate diet and high-fad diet (paired samples).
Measured: On day 12 of the respective diet
Secondary outcomes (2)
Enteroscopy: ketogenic activity in the small intestine
The biopsy material is fixed deep-frozen for later analyses.The ketonic activity is represented by the activity the ketogenic enzyme mitochondrial 3-hydroxy-3-methylglutaryl-CoA synthase (HMGCS2) in the tissue.
Immunofluorescence of antibodies (giving the geography in the duodenal/jejunal mucosa) and western blotting (semi-assessment compared to a steadily-expressed factor in the mucosa, glyceraldehyde 3-phosphate dehydrogenase (GAPDH). The HMGCS2 will be given as ratio to GAPDH. The western blots in the high-carbohydrate diet will be compared to high-fad diet in each individual (paired samples).
Measured: On day 14 of the respective diet
Enteroscopy: mucosal glucose-transport capacity
A part of the biopsy-material is kept a short time (<2h) in oxygenated preservation medium. The biopsies are then mounted in Ussing chambers for in-vitro functional studies. Activity of the sodium-glucose linked transporter 1 (SGLT1) is measured as the electrogenic response of 10 mM D-glucose, Iep (µA/mm2), given to the luminal compartment of the Ussing chamber. The net change is the % change of Iep from baseline in the glucose-free condition, to Iep after the addition of glucose to a concentration of 10%. The net change after the high-carbohydrate diet will be compared to the one after high-fat diet in each individual (paired samples).
Measured: On day 14 of the respective diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jun 2023
- Primary completion19 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Fändriks, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767177
- Sponsor's protocol ID
- Ketogen05
- Acronym
- But2
- Status last verified
- Apr 2025
- First submitted
- 16 Feb 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an exploratory studie with a rather small number of participants.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Intestinal Ketogenesis - Potential Significance for Type 2 Diabetes in Obesity
- ClinicalTrials.gov ID
- NCT05767177
- Acronym / sponsor ID
- But2 / Ketogen05
- Conditions
- Obesity, Morbid, Diabetes Mellitus, Type 2, Intestines, Incretins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 14 Mar 2023 (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 goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
Detailed description
The investigators have recently shown that the mucosa in the middle small intestine, the jejunum, in human volunteers produce ketones bodies.This situation is thus contrary to the common view that ketone bodies are formed by the liver during fasting/starvation. Obesity is commonly associated with hyperglycaemic conditions and diabetes mellitus type 2.This has given rise to the question of whether obesity results in disturbances in the intestinal food-induced ketogenesis and whether this influence contributes to the development of type 2 diabetes mellitus?
The project's questions are therefore:
- Does food intake-induced ketogenesis exist in the small intestine of obese individuals?
- Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
- If no to 2: What is the difference?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Carbohydrate Diet vs High Fat Diet | Experimental | Other: Glucemia following Mixed Meal Test, Other: Enteroscopy - mucosal ketogenic activity as well as glucose transportIn the current project, the situation applies to individuals with obesity (body mass index (BMI) 35 to 45 kg/m2). In one case the diet is of the type "high-carbohydrate diet" and in the other case "high-fat diet". The idea is that the research subjects should subsist on these diets for the respective 14 days. The energy content of the diet periods must be the same and correspond to the participants' daily needs. Each participant is drawn to one diet for 2 weeks. After a break of at least 3 weeks, the second diet is taken for 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 35 to 45 kg/m2
Key exclusion criteria (10 listed)
- Insulin-treated diabetes
- Sequelae of previous diabetes-associated disease (foot, eyes and kidneys, or cardiovascular incident, etc.)
- Diabetes, hypertension, lipid disorder that has not been stabilized for at least 1 month by adequate pharmacological treatment
- Continuous NSAID use
- Preferably otherwise medication-free (exceptions can be made)
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 |
|---|---|---|
| Glucemia following Mixed Meal TestOn day 12 of each diet, a venous catheter is placed in one arm for blood sampling and the research person must answer questions about any gastrointestinal complaints in connection with the current diet. At approximately 09:00, the research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal). Venous blood samples are taken before and 15, 30, 45, 60, 90 and 120 minutes after the meal. | Other | High Carbohydrate Diet vs High Fat Diet |
| Enteroscopy - mucosal ketogenic activity as well as glucose transportOn day 14 of each diet period, an enteroscopy is performed. This step is performed to obtain samples (biopsy) of the mucosa of the small intestine (duodenum and jejunum) and is performed at the Gastro-endoscopic departments SU-Sahlgrenska, or SU-Eastern hospital. Endoscopy is experienced by some individuals as unpleasant, which is why local anesthesia and sometimes sedation (midazolam + pethidine or rapifen) can be offered according to standard routine in the endoscopy department. | Other | High Carbohydrate Diet vs High Fat Diet |
Primary outcome
Glucemia following a Mixed Meal Test:
Time frame: On day 12 of the respective diet
The study participant arrives fasted and a venous catheter is placed in one arm for blood sampling. The research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal) and the p-glucose (mM) is checked at 120 min. The glucemia after the test meal will be compared in high-carbohydrate diet and high-fad diet (paired samples).
2 secondary outcomes
Enteroscopy: ketogenic activity in the small intestine
Time frame: On day 14 of the respective diet
Enteroscopy: mucosal glucose-transport capacity
Time frame: On day 14 of the respective diet
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 25 Apr 2025.
- Individual participant dataSharing planned: No. This is an exploratory studie with a rather small number of participants.
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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.
Lars Fändriks, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucemia following Mixed Meal Test and Enteroscopy - mucosal ketogenic activity as well as glucose transport in people with Obesity, Morbid and Diabetes Mellitus, Type 2, run by Göteborg University at 1 site in Sweden.
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 1 inclusion and 10 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 25 Apr 2025. 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 Sweden. 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?
Glucemia following a Mixed Meal Test: (time frame: On day 12 of the respective diet). 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 25 Apr 2025.