Obesity, MorbidDIABARNCT03330756
The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus
A study testing laparoscopic Roux-en-Y gastric bypass and laparoscopic Mini gastric bypass in people with Obesity, Morbid and Type 2 Diabetes Mellitus, run by Slotervaart Hospital at 1 site in Netherlands.
Trial summary
It is estimated that there will be 439-552 million people with type 2 diabetes mellitus (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Type 2 Diabetes Mellitus
- What is being tested?
- laparoscopic Roux-en-Y gastric bypass and laparoscopic Mini gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Oct 2017to 1 Nov 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥35 and ≤50 kg/m2
- Diagnosis and treatment of T2DM at intake at bariatric ward with use of anti-diabetic medication.
- American Society of Anaesthesiologist Classification (ASA) ≤3
- All patients are required to lose 6 kilograms of weight prior to surgery
Who cannot join
- Known genetic basis for insulin resistance or glucose intolerance
- Type 1 DM
- Prior Bariatric surgery
- Patients requiring a concomitant intervention (such as cholecystectomy, ventral hernia repair)
- Auto-immune gastritis
- Known presence of gastro-esophageal reflux disease
Show all 16Show fewer
- Known presence of large hiatal hernia requiring concomitant surgical repair
- Coagulation disorders (PT time > 14 seconds, aPTT ((dependent on laboratory methods) or known presence of bleeding disorders (anamnestic))
- Known presence of hemoglobinopathy
- Uncontrolled hypertension (RR > 150/95 mmHg)
- Renal insufficiency (creatinine > 150 umol/L)
- Pregnancy
- Breastfeeding
- Alcohol or drug dependency
- Primary lipid disorder
- Participation in any other (therapeutic) study that may influence primary or secondary outcomes
Trial locations and contacts
1 site in 1 country.
Maurits de Brauw, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
medical Center Slotervaart
Amsterdam, North Holland, 1066EC
Anne-Sophie van Rijswijk, MD, +31205014460, anne-sophie.vanrijswijk@slz.nl
Maurtis de Brauw, MD PhD, maurits.debrauw@slz.nl
About this study
Official title: The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and the Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus and the Pathophysiological Mechanisms That Drive the Conversion of Malign to Benign Obesity
It is estimated that there will be 439-552 million people with type 2 diabetes mellitus (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. It is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH). It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown.Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.
Read the detailed description
Metabolic surgery has proven to be a viable long-term solution in the treatment of morbid obesity and its comorbidities. It induces rapid remission of type 2 diabetes mellitus (T2DM). Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH), with the latter becoming the major indication for liver transplantation in the USA. It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown. Also, it is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. The Laparoscopic Roux-en-Y Gastric Bypass (LRYGB), an efficient but complex procedure, is the golden standard in the Netherlands. The Laparoscopic Mini Gastric Bypass (LMGB) is technically less challenging and has been introduced to overcome some of the limitations of LRYGB. It has been hypothesized that the LMGB has a more rapid and durable glycaemic control, possibly due to the altered constitution and the augmented length of the biliary limb. There is reason to believe that the improved glycaemic control might become apparent within the first year of surgery and that it might remain thereafter. However, it is unknown what order of magnitude is to be expected and whether subgroups of T2DM patients will benefit the LMGB more. Also, it is unknown whether and to what extent intestinal microbiota and immunological tone can predict the metabolic response (improvement in insulin sensitivity) and NAFLD/NASH reduction and whether differences are expected between these two surgeries. Increased understanding of the pathophysiological mechanisms as well as their relationship to metabolic disturbances are thought to be of crucial importance to discover new diagnostic and therapeutical targets in obesity associated insulin resistance/T2DM and NAFLD/NASH. Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.
- Conditions
- Obesity, Morbid, Type 2 Diabetes Mellitus
- Being tested
- laparoscopic Roux-en-Y gastric bypass, laparoscopic Mini gastric bypass
- Keywords
- Roux-en-Y gastric bypass, Mini gastric bypass, Type 2 diabetes mellitus, Morbid Obesity
- 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.
laparoscopic Roux-en-Y gastric bypassProcedure or surgery
Also called gastric bypass
laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb
laparoscopic Mini gastric bypassProcedure or surgery
Also called One anastomosis gastric bypass, omega loop gastric bypass
laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | Active comparator | Laparoscopic Roux-en-Y gastric bypass Receives: Procedure: laparoscopic Roux-en-Y gastric bypass |
| Laparoscopic Mini Gastric Bypass | Experimental | laparoscopic Mini gastric bypass Receives: Procedure: laparoscopic Mini gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycaemic control
as measured by the difference in HBa1C
Measured: 12 months FU
Secondary outcomes (21)
glycaemic control
as measured by the difference in HBa1C
Measured: 6 and 24 months FU
glycaemic control
as measured by the difference in HBa1C and anti-diabetic medication
Measured: 6, 12 and 24 months FU
Insulin sensitivity
Mixed meal tolerance test for level of insulin sensitivity
Measured: baseline, 12, 24 months FU
NAFLD/NASH
NAFLD/NASH parameters in liver biopsy measured with the Steatosis, Activity and Fibrosis (SAF) score according to Bedossa et al (2012).For each patient a SAF score summarizing the main histological lesions will be defined. The steatosis score (S) will assess the quantities of larger or median-sized lipid droplets but not foamy microvesicules from 0 to 3 (S0 <5%; S1 5-33%; S2 34-66% and S3>67%). Activity grade (A) from 0-4 is the unweighted addition of hepatocyte ballooning (0-2) and lobular inflammation (0-2). Stage of fibrosis will be assessed using the score described by NASH-CRN as follows; stage 0 (F0) no fibrosis; stage 1 (F1) 1a or 1b perisinusoidal zone 3 or 1c portal fibrosis; stage 2 (F2) persinusoidal and periportal fibrosis without bridging; stage 3 (F3) bridging fibrosis and stage 4 (F4) cirrhosis. A diagnostic algorithm which will be used during this study can be found in the original paper published by Bedossa et al.
Measured: day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - portal vein
in portal vein blood
Measured: day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - liver
in liver
Measured: day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - abdominal adipose tissue
in abdominal adipose tissue depots
Measured: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - GALT
in GALT
Measured: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - abdominal adipose tissue
in abdominal adipose tissue depots
Measured: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - liver
in liver
Measured: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - peripheral blood
in peripheral blood
Measured: day of surgery, reoperation
Expression and differentiation of immunological cells
ILC's, macrophages
Measured: 12 and 24 months FU
Expression and differentiation of inflammatory markers
IL6, IRX3 and 5
Measured: 12 and 24 months FU
Small intestinal and fecal microbiota composition
feces
Measured: 2, and 6 weeks, 6 months, as well as 12 and 24 months after surgery
Peripheral blood inflammatory markers
ILC's, macrophages, T/B-cells and dendritic cells
Measured: 2, and 6 weeks, 6 months, as well as 12 and 24 months after surgery
Eating habits
G-food craving questionnaire (FCQ-T) 21 item questionaire scale 0 (never) - 6 (always)
Measured: baseline, 12, 24 months FU
Eating habits
10 questions, scale 0-10 for instance 0 not hungry -10 very hungry / satiety / craving salty food / craving sweet food / craving fat food
Measured: baseline, 12, 24 months FU
Excreted metabolites
urine
Measured: baseline, 12, 24 months FU
Bio electric impedance
body composition as assesed by bioelectical impedance analysis (BIA): the measurement of body fat in relation to lean body mass.
Measured: baseline, 12, 24 months FU
Quality of life
Quality of life (IWQOL lite) 5 domain questionaire, 31 items: 1 never true - 5 always true
Measured: baseline, 12, 24 months FU
Cardiac / ventricular hypertrophy
Electrocardiogram (ECG)
Measured: baseline, 12, 24 months FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Oct 2017
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slotervaart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurits de Brauw, MD PhD, Principal investigator, Head of department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330756
- Sponsor's protocol ID
- P1729
- Acronym
- DIABAR
- Status last verified
- Nov 2017
- First submitted
- 13 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pyykko JE, Hinnen C, Aydin O, Nieuwdorp M, De Brauw LM, Bruin SC, van Olst N, Gerdes VEA, Sanderman R, Hagedoorn M. Attachment style and post-bariatric surgery health behaviours: the mediating role of self-esteem and health self-efficacy. BMC Psychol. 2023 Aug 25;11(1):248. doi: 10.1186/s40359-023-01273-5.
PubMed 37626349van Rijswijk A, van Olst N, Meijnikman AS, Acherman YIZ, Bruin SC, van de Laar AW, van Olden CC, Aydin O, Borger H, Beuers UHW, Herrema H, Verheij J, Apers JA, Backhed F, Gerdes VEA, Nieuwdorp M, de Brauw LM. The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial). Trials. 2022 Oct 22;23(1):900. doi: 10.1186/s13063-022-06762-3.
PubMed 36273149
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and the Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus and the Pathophysiological Mechanisms That Drive the Conversion of Malign to Benign Obesity
- ClinicalTrials.gov ID
- NCT03330756
- Acronym / sponsor ID
- DIABAR / P1729
- Conditions
- Obesity, Morbid, Type 2 Diabetes Mellitus
- Keywords
- Roux-en-Y gastric bypass, Mini gastric bypass, Type 2 diabetes mellitus, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Slotervaart HospitalUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 6 Nov 2017 (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.
It is estimated that there will be 439-552 million people with type 2 diabetes mellitus (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. It is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH). It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown.Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.
Detailed description
Metabolic surgery has proven to be a viable long-term solution in the treatment of morbid obesity and its comorbidities. It induces rapid remission of type 2 diabetes mellitus (T2DM). Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpatient clinic. Non alcoholic fatty liver disease (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for development of insulin resistance and non alcoholic steatohepatis (NASH), with the latter becoming the major indication for liver transplantation in the USA. It is increasingly recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the intestinal microbiome are major players in this obesity related disease and the switch from benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of action behind the surgery-driven switch back from malign to benign obesity are unknown. Also, it is undecided which metabolic surgery grants best results in the remission of T2DM and which procedure does that at the lowest rate of surgical complications, long term difficulties and side effects. The Laparoscopic Roux-en-Y Gastric Bypass (LRYGB), an efficient but complex procedure, is the golden standard in the Netherlands. The Laparoscopic Mini Gastric Bypass (LMGB) is technically less challenging and has been introduced to overcome some of the limitations of LRYGB. It has been hypothesized that the LMGB has a more rapid and durable glycaemic control, possibly due to the altered constitution and the augmented length of the biliary limb. There is reason to believe that the improved glycaemic control might become apparent within the first year of surgery and that it might remain thereafter. However, it is unknown what order of magnitude is to be expected and whether subgroups of T2DM patients will benefit the LMGB more. Also, it is unknown whether and to what extent intestinal microbiota and immunological tone can predict the metabolic response (improvement in insulin sensitivity) and NAFLD/NASH reduction and whether differences are expected between these two surgeries. Increased understanding of the pathophysiological mechanisms as well as their relationship to metabolic disturbances are thought to be of crucial importance to discover new diagnostic and therapeutical targets in obesity associated insulin resistance/T2DM and NAFLD/NASH. Primary objective is to evaluate and compare the glycaemic control in T2DM within the first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological mechanisms that drive the conversion of malign to benign obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, open randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | Active comparator | Procedure: laparoscopic Roux-en-Y gastric bypassLaparoscopic Roux-en-Y gastric bypass |
| Laparoscopic Mini Gastric Bypass | Experimental | Procedure: laparoscopic Mini gastric bypasslaparoscopic Mini gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥35 and ≤50 kg/m2
- Diagnosis and treatment of T2DM at intake at bariatric ward with use of anti-diabetic medication.
- American Society of Anaesthesiologist Classification (ASA) ≤3
- All patients are required to lose 6 kilograms of weight prior to surgery
Key exclusion criteria (16 listed)
- Known genetic basis for insulin resistance or glucose intolerance
- Type 1 DM
- Prior Bariatric surgery
- Patients requiring a concomitant intervention (such as cholecystectomy, ventral hernia repair)
- Auto-immune gastritis
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 |
|---|---|---|
| laparoscopic Roux-en-Y gastric bypassAlso: gastric bypasslaparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb | Procedure or surgery | Laparoscopic Roux-en-Y gastric bypass |
| laparoscopic Mini gastric bypassAlso: One anastomosis gastric bypass, omega loop gastric bypasslaparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz | Procedure or surgery | Laparoscopic Mini Gastric Bypass |
Primary outcome
glycaemic control
Time frame: 12 months FU
as measured by the difference in HBa1C
21 secondary outcomes
glycaemic control
Time frame: 6 and 24 months FU
glycaemic control
Time frame: 6, 12 and 24 months FU
Insulin sensitivity
Time frame: baseline, 12, 24 months FU
NAFLD/NASH
Time frame: day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - portal vein
Time frame: day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - liver
Time frame: day of surgery, reoperation
Presence of bacterial DNA/bacterial metabolites - abdominal adipose tissue
Time frame: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - GALT
Time frame: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - abdominal adipose tissue
Time frame: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - liver
Time frame: day of surgery, reoperation
Expression and differentiation of intestinal immunological cells - peripheral blood
Time frame: day of surgery, reoperation
Expression and differentiation of immunological cells
Time frame: 12 and 24 months FU
Expression and differentiation of inflammatory markers
Time frame: 12 and 24 months FU
Small intestinal and fecal microbiota composition
Time frame: 2, and 6 weeks, 6 months, as well as 12 and 24 months after surgery
Peripheral blood inflammatory markers
Time frame: 2, and 6 weeks, 6 months, as well as 12 and 24 months after surgery
Eating habits
Time frame: baseline, 12, 24 months FU
Eating habits
Time frame: baseline, 12, 24 months FU
Excreted metabolites
Time frame: baseline, 12, 24 months FU
Bio electric impedance
Time frame: baseline, 12, 24 months FU
Quality of life
Time frame: baseline, 12, 24 months FU
Cardiac / ventricular hypertrophy
Time frame: baseline, 12, 24 months FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Derived from this study: PubMed 37626349Pyykko JE, Hinnen C, Aydin O, Nieuwdorp M, De Brauw LM, Bruin SC, van Olst N, Gerdes VEA, Sanderman R, Hagedoorn M. Attachment style and post-bariatric surgery health behaviours: the mediating role of self-esteem and health self-efficacy. BMC Psychol. 2023 Aug 25;11(1):248. doi: 10.1186/s40359-023-01273-5.
- Derived from this study: PubMed 36273149van Rijswijk A, van Olst N, Meijnikman AS, Acherman YIZ, Bruin SC, van de Laar AW, van Olden CC, Aydin O, Borger H, Beuers UHW, Herrema H, Verheij J, Apers JA, Backhed F, Gerdes VEA, Nieuwdorp M, de Brauw LM. The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial). Trials. 2022 Oct 22;23(1):900. doi: 10.1186/s13063-022-06762-3.
- 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.
Maurits de Brauw, MD PhD contact
Maurits de Brauw, MD PhD principal investigator
Head of department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic Roux-en-Y gastric bypass and laparoscopic Mini gastric bypass in people with Obesity, Morbid and Type 2 Diabetes Mellitus, run by Slotervaart Hospital at 1 site in Netherlands.
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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie van Rijswijk, MD (+31205124460, anne-sophie.vanrijswijk@slz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycaemic control (time frame: 12 months FU). 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 NCT03330756, which also lists 2 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 9 Nov 2017.