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Diabetes Mellitus, Type 2Phase 3NCT05211375

Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial

A Phase 3 study testing Duodenojejunal bypass and Sleeve gastrectomy in people with Diabetes Mellitus, Type 2 and Bariatric Surgery, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Duodenojejunal bypass and Sleeve gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSouth Korea
Study dates
3 Jan 2022to 3 Jan 2036
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age over 18 years
  • BMI equal to or greater than 27.5 kg/m2
  • T2DM duration ≤ 10 years
  • Using insulin, or HbA1c ≥ 7.0% while taking diabetes medication
  • C-peptide level higher than 1.0 ng/mL
  • Presence of type 2 diabetes fulfilling the following criteria
  • Consent to not become pregnant for at least 1 year after surgery
  • Willingness to provide voluntary informed consent

Who cannot join

  • Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more in esophagogastroduodenoscopy)
  • History of previous metabolic surgery for T2DM
  • History of gastrointestinal surgery, such as gastrectomy or anti-reflux surgery, which may affect the result of metabolic surgery
  • Therapy regimen of more than 3 psychiatric drugs owing to poorly controlled psychiatric disorders
  • Suicidal attempts within the last 12 months
  • Treatment for alcohol and drug abuse within the last 12 months
  • Vulnerability factors (lacking mental capacity, pregnancy or planning of pregnancy, lactation)
  • Unsuitability as per the discretion of the researcher

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Young Suk Park contact

+82-10-8980-6094

youngsukmd@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Young Suk Park, youngsukmd@gmail.com

    Recruiting

Other trials in South Korea

About this study

In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM).

This study is to target patients with poor blood sugar control despite current medical treatment, although the beta-cell function of the pancreas is preserved. Therefore, this study is aimed at patients who have been using insulin for less than 10 years with T2DM, or taking diabetic medications with HbA1c ≥ 7.0% for less than 10 years with T2DM.

The investigators hypothesize that the treatment effects of SG with DJB for T2DM will be superior to that of SG in this group

Read the detailed description

Most Asian patients undergoing metabolic surgery for the treatment of T2DM have BMI as low as 30-35 kg/m2. If SG is performed for the treatment of T2DM in these patients, weight may decrease after the surgery; however, T2DM may recur after 6 months to 1 year. Therefore, it is difficult to find clinical studies on SG for metabolic surgery in Asians, and gastric bypass may be more appropriate as metabolic surgery. However, gastroscopy for the remnant stomach after gastric bypass is practically impossible. Therefore, gastric bypass may be a fatal drawback for East Asian patients with a high incidence of gastric cancer. In recent years, modified duodenal switch (SG with duodenojejunal bypass [DJB], which is defined as the procedure that makes jejunal bypass shorter than the traditional duodenal switch) is often performed as metabolic surgery, and studies on this surgical technique are being actively conducted in Japan.

SG with DJB has both effects of stomach restriction and foregut bypass. However, SG with DJB is more disadvantageous compared to SG alone in nutrient absorption after surgery. This is a natural result of bypassing the duodenum and proximal jejunum. Therefore, SG with DJB should not be performed when it is unnecessary, and it should be performed in patients who are expected to show significant improvement in T2DM. However, there is no existing guideline on which patients can receive SG with DJB or SG alone, and there are also no clinical studies on these aspects.

Being tested
Duodenojejunal bypass, Sleeve gastrectomy
Keywords
Bariatric Surgery, Metabolic Surgery, Diabetes Remission
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.

  • Duodenojejunal bypassProcedure or surgery

    Sleeve gastrectomy will be performed in the same manner as in the SG group. DJB will be performed by transection of the duodenum and bypassing 250 cm of the proximal jejunum. The handsewn suture will be used for duodenojejunal anastomosis, and the size of anastomosis will be 1.5 - 2 cm. Single anastomosis will be performed rather than Roux-en-Y fashion.

  • Sleeve gastrectomyProcedure or surgery

    Sleeve gastrectomy will be performed using 36-38 Fr bougie. The initial stapling start point will be between 4-6 cm from the pylorus, and the last stapling will be performed at least 1 cm away from His angle. The height of the automatic stapler will be selected based on the researcher's discretion.

Study groups in NCT05211375
Study groupRoleWhat they receive
SG groupActive comparatorPatients undergoing sleeve gastrectomy
Receives: Procedure: Sleeve gastrectomy
DJB groupExperimentalPatients undergoing duodenojejunal bypass with sleeve gastrectomy
Receives: Procedure: Duodenojejunal bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission rate of type 2 diabetes

    HbA1c <6% (or fasting blood glucose [FBG] <100 mg/dL) without using any diabetes medication

    Measured: 5 years after surgery

Secondary outcomes (14)

  1. Complete remission rate of type 2 diabetes

    HbA1c <6% (or fasting blood glucose [FBG] <100 mg/dL) without using any diabetes medication

    Measured: 1, 3, 10 years after surgery

  2. Partial remission rate of type 2 diabetes

    Definition of partial remission of diabetes: HbA1c of 6-6.4% (or FBG of 100-125 mg/dL) without using any diabetes medication

    Measured: 1, 3, 5, 10 years after surgery

  3. Improvement rate of type 2 diabetes

    Definition of improvement of diabetes: Significant reduction in HbA1c (or FBG) level or decrease in the number of diabetic drugs or stoppage of insulin that does not meet the definition of remission.

    Measured: 1, 3, 5, 10 years after surgery

  4. Hypertension remission rate

    Definition of complete remission of hypertension: Blood pressure (BP) <120/80 mmHg without taking BP medication Definition of partial remission of hypertension: BP of 120-140/80-89 mmHg without taking BP medication

    Measured: 1, 3, 5, 10 years after surgery

  5. Hypertension improvement rate

    Definition of improvement of hypertension: Decrease in the number or dose of BP medications or decreased BP while taking medication

    Measured: 1, 3, 5, 10 years after surgery

  6. Hyperlipidemia remission rate

    Definition of remission of hyperlipidemia: Normal lipid profile (triglyceride [TG] <150 mg/dL and low-density lipoprotein [LDL] of 129 mg/dL or less and high-density lipoprotein [HDL] of 40 mg/dL or above) without taking hyperlipidemic drugs

    Measured: 1, 3, 5, 10 years after surgery

  7. Hyperlipidemia improvement rate

    Definition of improvement of hyperlipidemia: Reduced number or dose of hyperlipidemic drugs or improved lipid profile while taking hyperlipidemic drugs

    Measured: 1, 3, 5, 10 years after surgery

  8. Prevalence of GERD

    Acid reflux symptoms and positive endoscopic findings (LA classification A or more)

    Measured: 1, 3, 5, 10 years after surgery

  9. Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn])

    Iron deficiency: ferritin <20 ng/mL or iron <50 mcg/dL Vitamin B12 deficiency: <200 pg/mL, vitamin B12 suboptimal: 200 - <400 pg/mL Folate deficiency: <10nmol/L (4.4ng/mL) Vitamin B1 deficiency: <2.36 mcg/dL Vitamin D deficiency: <20 mg/mL, vitamin D insufficiency: 20-<30 ng/mL Cu deficiency: <75 mcg/dL Zn deficiency: <70 mcg/dL in women, < 74 mcg/dL in men

    Measured: 1, 3, 5, 10 years after surgery

  10. Changes in body weight

    kilograms

    Measured: 1, 3, 5, 10 years after surgery

  11. Changes in body composition

    body fat percentage(%), body fat mass (kg), and muscle mass(kg)

    Measured: 1, 3, 5, 10 years after surgery

  12. Changes in Quality of life

    IWQOL-Lite, SF-12

    Measured: 1, 3, 5, 10 years after surgery

  13. Early complication rate

    Measured: Early: within 30 days after surgery

  14. Late complication rate

    Measured: Late: later than 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start3 Jan 2022
  3. Primary completion3 Jan 2031 (estimated)
  4. Study completion3 Jan 2036 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211375
Sponsor's protocol ID
MEDUSA
Status last verified
Jan 2022
First submitted
4 Jan 2022
Last updated
27 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hofso D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Smastuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesaeth J. Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Dec;7(12):912-924. doi: 10.1016/S2213-8587(19)30344-4. Epub 2019 Oct 31.

    PubMed 31678062

  • Aminian A, Brethauer SA, Andalib A, Nowacki AS, Jimenez A, Corcelles R, Hanipah ZN, Punchai S, Bhatt DL, Kashyap SR, Burguera B, Lacy AM, Vidal J, Schauer PR. Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity. Ann Surg. 2017 Oct;266(4):650-657. doi: 10.1097/SLA.0000000000002407.

    PubMed 28742680

  • Brethauer SA, Kim J, el Chaar M, Papasavas P, Eisenberg D, Rogers A, Ballem N, Kligman M, Kothari S; ASMBS Clinical Issues Committee. Standardized outcomes reporting in metabolic and bariatric surgery. Surg Obes Relat Dis. 2015 May-Jun;11(3):489-506. doi: 10.1016/j.soard.2015.02.003. No abstract available.

    PubMed 26093765

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duodenojejunal bypass and Sleeve gastrectomy in people with Diabetes Mellitus, Type 2 and Bariatric Surgery, run by Seoul National University Bundang Hospital at 1 site in South Korea.

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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Jan 2022. 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 South Korea. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Young Suk Park (+82-10-8980-6094, youngsukmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate of type 2 diabetes (time frame: 5 years after surgery). 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 NCT05211375, 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 27 Jan 2022.

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