Type 2 DiabetesNCT01086111
The Effect of a Gastric Bypass on Type 2 Diabetes in the Morbidly Obese Patient
An observational study of Type 2 Diabetes and Morbid Obesity, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery. The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Morbid Obesity
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetes patients with a BMI > 35kg/m²
Who may be able to join
- Female or male subjects aged 18 to 65
- BMI > 35 kg/m2
- Subject is capable and willing to give informed consent.
- In the surgical groups indication for surgery is approved by the local multidisciplinary obesity workgroup following the NIH guidelines of 199112.
- Patient suffers from type 2 diabetes necessitating insulin therapy.
- Subject is a non-smoker for at least 6 months prior to study start.
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- Female patients of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the screening visit. Patients using hormonal contraception should use a barrier method in addition from screening visit until their next normal period following the end of the study.
- Female patients of non-child bearing potential defined as:
- Post-menopausal females, being amenorrhoeic for at least 1 year
- Pre-menopausal females with a documented hysterectomy or bilateral oophorectomy.
Who cannot join
- Female patient is pregnant or breastfeeding.
- BMI < 35 kg/m2
- Patient suffers from an endocrine disease, besides diabetes and thyroid disease, such as Cushing's disease, Addison's disease, hypothalamic tumor…)
- Patient suffers from type 1 diabetes, MODY or LADA
- Patient has undergone previous surgical procedure for weight loss
- Patient is considered ASA 4 or more according to the ASA physical status classification system of the American Society of Anesthesiologists.
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- Patient suffers from liver cirrhosis
- Patient uses steroids
- Patient uses cyclosporin
- Recent (<30 days) or simultaneous participation in another clinical trial.
- Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass
Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery.
The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and early postoperatively.
Read more
Aims \& methodology:
Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin sensitivity and beta cell function.
Preoperative baseline insulin sensitivity and beta cell function will be assessed with euglycemic and hyperglycemic clamp tests. These results will be compared with the results of the same tests carried out 3 weeks postoperative.
To determine if the duodenal exclusion is causing this effect. The results of the clamp tests 3 weeks postoperative will be compared
- Conditions
- Type 2 Diabetes, Morbid Obesity
- Keywords
- type 2 diabetes, gastric bypass, sleeve gastrectomy, clamp study, weight loss surgery
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Morbid
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 |
|---|---|---|
| PMSF | type 2 diabetes patient receiving a protein sparing diet | |
| sleeve gastrectomy | type 2 diabetes patient receiving a gastric bypass | |
| RYGBP | type 2 diabetes patient receiving a gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity and beta cell function
insulin sensitivity and beta cell function changes 3 weeks after RYGB, sleeve gastrectomy and protein sparing diet using euglycaemic and hyperglycemic clamp techniques.
Measured: 3 weeks
Secondary outcomes (1)
changes in plasma levels of gut hormones and inflammation markers
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Lannoo, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086111
- Sponsor's protocol ID
- S51169
- Status last verified
- Dec 2015
- First submitted
- 10 Mar 2010
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass
- ClinicalTrials.gov ID
- NCT01086111
- Acronym / sponsor ID
- S51169
- Conditions
- Type 2 Diabetes, Morbid Obesity
- Keywords
- type 2 diabetes, gastric bypass, sleeve gastrectomy, clamp study, weight loss surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Mar 2010 (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.
Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery.
The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and early postoperatively.
Aims \& methodology:
Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin sensitivity and beta cell function.
Preoperative baseline insulin sensitivity and beta cell function will be assessed with euglycemic and hyperglycemic clamp tests. These results will be compared with the results of the same tests carried out 3 weeks postoperative.
To determine if the duodenal exclusion is causing this effect. The results of the clamp tests 3 weeks postoperative will be compared
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMSF | – | –type 2 diabetes patient receiving a protein sparing diet |
| sleeve gastrectomy | – | –type 2 diabetes patient receiving a gastric bypass |
| RYGBP | – | –type 2 diabetes patient receiving a gastric bypass |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetes patients with a BMI > 35kg/m²
Key inclusion criteria (10 listed)
- Female or male subjects aged 18 to 65
- BMI > 35 kg/m2
- Subject is capable and willing to give informed consent.
- In the surgical groups indication for surgery is approved by the local multidisciplinary obesity workgroup following the NIH guidelines of 199112.
- Patient suffers from type 2 diabetes necessitating insulin therapy.
Key exclusion criteria (11 listed)
- Female patient is pregnant or breastfeeding.
- BMI < 35 kg/m2
- Patient suffers from an endocrine disease, besides diabetes and thyroid disease, such as Cushing's disease, Addison's disease, hypothalamic tumor…)
- Patient suffers from type 1 diabetes, MODY or LADA
- Patient has undergone previous surgical procedure for weight loss
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
insulin sensitivity and beta cell function
Time frame: 3 weeks
insulin sensitivity and beta cell function changes 3 weeks after RYGB, sleeve gastrectomy and protein sparing diet using euglycaemic and hyperglycemic clamp techniques.
1 secondary outcome
changes in plasma levels of gut hormones and inflammation markers
Time frame: 3 weeks
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 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 Diabetes and Morbid Obesity, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 10 inclusion and 11 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 2015. 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 Belgium. 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?
insulin sensitivity and beta cell function (time frame: 3 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 4 Dec 2015.