Type II DiabetesNCT01330251
The Effect of Gastric Bypass Surgery on Diabetes
An observational study of Type II Diabetes, run by University of Oulu at 1 site in Finland.
Trial summary
This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type II Diabetes
- How many people
- 41 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Dec 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients are recruited from Oulu University Hospital
Who may be able to join
- Patients having Roux-en-Y gastric bypass (according to clinical guidelines)
- Age: 18-65 years
- Patients having gastroscopy (for various clinical reasons)
Who cannot join
- Diabetes (applies for control patients)
- BMI over 30 (applies for control patients)
- Insulin treatment
- Oral corticosteroid treatment
- Chronic inflammatory disease
- Coeliac disease
- Malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laihdutusleikkauksen Vaikutus Diabetekseen
This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. Meal test with incretin measurements, and feces and blood samplings are performed before and after surgery
Hypotheses are:
Read more
- The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells
- The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes
- The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis
- The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation
- The gastric bypass surgery changes cholesterol and bile acid metabolism
- The gastric bypass surgery changes the fecal microbiota
Primary end points are:
- Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
- Changes in the incretine secretion studied with liquid meal test
- Changes in the oxidation of lipoproteins
- Changes in the immunologic markers in ventricle, duodenum and jejunum
- Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
- Changes in fecal microbiota
- Conditions
- Type II Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes having Roux-en-Y gastric bypass | Not described | |
| Patients without diabetes having Roux-en-Y gastric bypass | Not described | |
| Control subjects (patients having gastroscopy, no surgery) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Measured: baseline to 6 months
Changes in the incretine secretion studied with liquid meal test
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Measured: baseline to 6 months
Changes in the oxidation of lipoproteins
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Measured: baseline to 6 months
Changes in the immunologic markers in ventricle, duodenum and jejunum
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Measured: baseline to 6 months
Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Measured: baseline to 6 months
Changes in fecal microbiota
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies 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
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Vesa Koivukangas, MD, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330251
- Sponsor's protocol ID
- Laihdutusleikkaustutkimus
- Status last verified
- Oct 2017
- First submitted
- 22 Mar 2011
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
PubMed 41744113Zhao S, Horkko S, Savolainen MJ, Koivukangas V, Makinen VP, Ala-Korpela M, Hukkanen J. Short-Term Metabolic Changes and Their Physiological Mediators in the Roux-en-Y Gastric Bypass Bariatric Surgery. Obes Surg. 2024 Feb;34(2):625-634. doi: 10.1007/s11695-023-07042-y. Epub 2024 Jan 9.
PubMed 38191968Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
PubMed 35229613
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laihdutusleikkauksen Vaikutus Diabetekseen
- ClinicalTrials.gov ID
- NCT01330251
- Acronym / sponsor ID
- Laihdutusleikkaustutkimus
- Conditions
- Type II Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Apr 2011 (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.
This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. Meal test with incretin measurements, and feces and blood samplings are performed before and after surgery
Hypotheses are:
- The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells
- The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes
- The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis
- The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation
- The gastric bypass surgery changes cholesterol and bile acid metabolism
- The gastric bypass surgery changes the fecal microbiota
Primary end points are:
- Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
- Changes in the incretine secretion studied with liquid meal test
- Changes in the oxidation of lipoproteins
- Changes in the immunologic markers in ventricle, duodenum and jejunum
- Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
- Changes in fecal microbiota
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes having Roux-en-Y gastric bypass | – | – |
| Patients without diabetes having Roux-en-Y gastric bypass | – | – |
| Control subjects (patients having gastroscopy, no surgery) | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are recruited from Oulu University Hospital
Key inclusion criteria (3 listed)
- Patients having Roux-en-Y gastric bypass (according to clinical guidelines)
- Age: 18-65 years
- Patients having gastroscopy (for various clinical reasons)
Key exclusion criteria (7 listed)
- Diabetes (applies for control patients)
- BMI over 30 (applies for control patients)
- Insulin treatment
- Oral corticosteroid treatment
- Chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
Time frame: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the incretine secretion studied with liquid meal test
Time frame: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the oxidation of lipoproteins
Time frame: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the immunologic markers in ventricle, duodenum and jejunum
Time frame: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
Time frame: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in fecal microbiota
Time frame: baseline to 6 months
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
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 Nov 2017.
- Derived from this study: PubMed 41744113Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
- Derived from this study: PubMed 38191968Zhao S, Horkko S, Savolainen MJ, Koivukangas V, Makinen VP, Ala-Korpela M, Hukkanen J. Short-Term Metabolic Changes and Their Physiological Mediators in the Roux-en-Y Gastric Bypass Bariatric Surgery. Obes Surg. 2024 Feb;34(2):625-634. doi: 10.1007/s11695-023-07042-y. Epub 2024 Jan 9.
- Derived from this study: PubMed 35229613Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
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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.
Vesa Koivukangas, MD, PhD principal investigator
Oulu University Hospital
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 Type II Diabetes, run by University of Oulu at 1 site in Finland.
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 7 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 Nov 2017. 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 Finland. 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?
Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum (time frame: baseline to 6 months). The study lists 6 primary outcomes in all. 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 NCT01330251, which also lists 3 linked publications.
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 Nov 2017.