Type 2 DiabetesNCT01820273
Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy
An observational study of Type 2 Diabetes and Obesity, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2013to 1 Aug 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female obese (BMI>35)patients accepted for bariatric surgery (lap gastric bypass). 10 patients with type 2 diabetes(T2D) 6 10 matched controls without T2D.
Who may be able to join
- clinical diagnosis of type 2 diabetes
- obesity BMI >35
Who cannot join
- prior bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Incretins Response and Glycemic Control: Pre Diet, After Conventional Weight Loss and in the Early Postoperative Phase After Gastric Bypass in T2D-patients.
The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Type 2 diabetes, Bariatric surgery, incretines, GLP-1, GIP, gastric bypass, foregut, hindgut
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in incretines in the bariatric patient
standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.
Measured: 2 months prior to surgery - 6 weeks post surgery
Secondary outcomes (1)
Diabetes control
resolution of t2D as early as first day after surgery
Measured: 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completion1 May 2016
- Study completion1 Aug 2019
Why it stopped: Study no longer at LU.
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.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Kalmar County Hospital
- Responsible party
- Sponsor
- Investigators
- Nils Wierup, Study director, Lunds Universitet, Clinical researchcenterJohan Berggren, MD, Principal investigator, Lunds Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820273
- Sponsor's protocol ID
- MRD-Study
- Status last verified
- Aug 2019
- First submitted
- 25 Mar 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Incretins Response and Glycemic Control: Pre Diet, After Conventional Weight Loss and in the Early Postoperative Phase After Gastric Bypass in T2D-patients.
- ClinicalTrials.gov ID
- NCT01820273
- Acronym / sponsor ID
- MRD-Study
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Type 2 diabetes, Bariatric surgery, incretines, GLP-1, GIP, gastric bypass, foregut, hindgut
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study no longer at LU.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Kalmar County Hospital
- Study start
- Apr 2013
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Mar 2013 (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.
The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female obese (BMI>35)patients accepted for bariatric surgery (lap gastric bypass). 10 patients with type 2 diabetes(T2D) 6 10 matched controls without T2D.
Key inclusion criteria (2 listed)
- clinical diagnosis of type 2 diabetes
- obesity BMI >35
Key exclusion criteria (1 listed)
- prior bariatric surgery
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 incretines in the bariatric patient
Time frame: 2 months prior to surgery - 6 weeks post surgery
standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.
1 secondary outcome
Diabetes control
Time frame: 6 weeks post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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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.
Nils Wierup study director
Lunds Universitet, Clinical researchcenter
Johan Berggren, MD principal investigator
Lunds Universitet
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 Obesity, run by Lund 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Aug 2019. 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 was withdrawn before enrolling participants, so there are no results.
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 incretines in the bariatric patient (time frame: 2 months prior to surgery - 6 weeks post surgery). 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 7 Aug 2019.