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OverweightSIT-DOWN-1NCT02610530

Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1

An observational study of Overweight and Diabetes Mellitus, Type 2, run by Turkish Metabolic Surgery Foundation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety) participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus (T2DM) will be evaluated for the efficacy of surgical intervention in comparison with medical treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Diabetes Mellitus, Type 2
What is being tested?
Sleeve Gastrectomy with Ileal Transposition, Sleeve Gastrectomy with Transit Bipartition and Medical Treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Dec 2015to Oct 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: Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2

Who may be able to join

  • Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2
  • Participants with baseline HbA1c ≥ % 7.5, not achieved HbA1c < % 7.3 at 3 months on therapy
  • Absence of co-morbidities (neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation).

Who cannot join

  • Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness.
  • Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris.
  • History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act.
  • Pregnancy
  • Any conditions that at the discretion of the head of the study can represent risk to the participant or could affect the protocol results.

About this study

Official title: Efficacy of Surgical Intervention for the Treatment of Diabetes Mellitus Type 2 in Overweight Non-responders in Comparison With Conventional Nonsurgical Medical Treatment

The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety) participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus (T2DM) will be evaluated for the efficacy of surgical intervention in comparison with medical treatment. Primary endpoint of the study will be the change in glycemic regulation by the end of 12 months.

Read the detailed description

Use of bariatric/metabolic surgery has conventionally been reserved for those whose body-mass index (BMI) is 35 kg/m2 or greater. Trials in these morbidly obese patients confirmed the benefits in terms of weight loss and provide evidence that surgery can result in remission of diabetes, and as a result lead to improvement in cardiovascular risk factors. Within the light of these data, there appear to be a shift towards lower BMI, with many advocating it as a reasonable option for diabetics with a lower BMI (<30) who have failed other attempts of medical treatment. But this approach is limited because of lack of data on the effects of surgical outcomes in this group of patients which is the main rationale for this retrospective study.

Being tested
Sleeve Gastrectomy with Ileal Transposition, Sleeve Gastrectomy with Transit Bipartition, Medical Treatment
Keywords
type 2 diabetes, metabolic surgery, medical treatment
Medical subject headings
Overweight, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleeve Gastrectomy with Ileal TranspositionProcedure or surgery

    Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.

  • Sleeve Gastrectomy with Transit BipartitionProcedure or surgery

    Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.

  • Medical TreatmentOther

    Also called Oral antidiabetics and / or insulin

    Conventional Non-Surgical Treatment for Glycemic Control group consisted of patients who did not undergo any kind of surgery, and are on medical treatment for type 2 diabetes.

Study groups in NCT02610530
Study groupRoleWhat they receive
Non-SurgeryOverweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2 who have been on medical treatment for glycemic control.
Receives: Other: Medical Treatment
Surgery-AOverweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with ileal transposition
Receives: Procedure: Sleeve Gastrectomy with Ileal Transposition
Surgery-BOverweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with transit bipartition
Receives: Procedure: Sleeve Gastrectomy with Transit Bipartition

What is being measured

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

  1. Reduction in glycated hemoglobin (HbA1c)

    Complete diabetic remission (HbA1c < 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.

    Measured: 1 year

Secondary outcomes (5)

  1. Hypertension Control

    Systolic blood pressure (BP) <130 mm Hg and diastolic BP <80 mm Hg, without medication.

    Measured: 1 year

  2. Change in LDL (low-density lipoprotein) Cholesterol

    <100 mg/dL, without medication.

    Measured: 1 year

  3. Change in HDL (high-density lipoprotein) Cholesterol

    >40 mg/dL, without medication.

    Measured: 1 year

  4. Change in Triglycerides

    <150 mg/dL, without medication.

    Measured: 1 year

  5. Weight Control

    Amount of weight loss in kilograms.

    Measured: 1 year

Timeline

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

  1. First posted20 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2016
  4. Study completionOct 2016 (estimated)

Resources

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
Retrospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02610530
Sponsor's protocol ID
2015/S01
Acronym
SIT-DOWN-1
Status last verified
Jul 2016
First submitted
17 Nov 2015
Last updated
1 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • DePaula AL, Macedo AL, Schraibman V, Mota BR, Vencio S. Hormonal evaluation following laparoscopic treatment of type 2 diabetes mellitus patients with BMI 20-34. Surg Endosc. 2009 Aug;23(8):1724-32. doi: 10.1007/s00464-008-0168-6. Epub 2008 Oct 2.

    PubMed 18830747

  • Kashyap SR, Daud S, Kelly KR, Gastaldelli A, Win H, Brethauer S, Kirwan JP, Schauer PR. Acute effects of gastric bypass versus gastric restrictive surgery on beta-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes. Int J Obes (Lond). 2010 Mar;34(3):462-71. doi: 10.1038/ijo.2009.254. Epub 2009 Dec 22.

    PubMed 20029383

  • Finelli C, Padula MC, Martelli G, Tarantino G. Could the improvement of obesity-related co-morbidities depend on modified gut hormones secretion? World J Gastroenterol. 2014 Nov 28;20(44):16649-64. doi: 10.3748/wjg.v20.i44.16649.

    PubMed 25469034

  • Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25.

    PubMed 23439632

  • Santoro S. From Bariatric to Pure Metabolic Surgery: New Concepts on the Rise. Ann Surg. 2015 Aug;262(2):e79-80. doi: 10.1097/SLA.0000000000000590. No abstract available.

    PubMed 24646534

  • Celik A, Ugale S. Functional restriction and a new balance between proximal and distal gut: the tools of the real metabolic surgery. Obes Surg. 2014 Oct;24(10):1742-3. doi: 10.1007/s11695-014-1368-x. No abstract available.

    PubMed 25027983

  • Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.

    PubMed 22609843

  • De Paula AL, Stival AR, Halpern A, DePaula CC, Mari A, Muscelli E, Vencio S, Ferrannini E. Improvement in insulin sensitivity and beta-cell function following ileal interposition with sleeve gastrectomy in type 2 diabetic patients: potential mechanisms. J Gastrointest Surg. 2011 Aug;15(8):1344-53. doi: 10.1007/s11605-011-1550-6. Epub 2011 May 10.

    PubMed 21557013

  • De Paula AL, Stival AR, Macedo A, Ribamar J, Mancini M, Halpern A, Vencio S. Prospective randomized controlled trial comparing 2 versions of laparoscopic ileal interposition associated with sleeve gastrectomy for patients with type 2 diabetes with BMI 21-34 kg/m(2). Surg Obes Relat Dis. 2010 May-Jun;6(3):296-304. doi: 10.1016/j.soard.2009.10.005. Epub 2009 Nov 10.

    PubMed 20096647

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Diabetes Mellitus, Type 2, run by Turkish Metabolic Surgery Foundation.

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 5 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Reduction in glycated hemoglobin (HbA1c) (time frame: 1 year). 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 NCT02610530, which also lists 9 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 Aug 2016.

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