Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1 (SIT-DOWN-1)

July 29, 2016 updated by: Turkish Metabolic Surgery Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-Surgery
Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2 who have been on medical treatment for glycemic control.
Other: Medical Treatment
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.
Other Names:
  • Oral antidiabetics and / or insulin
Surgery-A
Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with ileal transposition
Procedure: Sleeve Gastrectomy with Ileal Transposition
Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.
Surgery-B
Overweight diabetic, type 2 diabetes diagnosis longer than 3 years; BMI:25-29.9 kg/m2. who underwent sleeve gastrectomy with transit bipartition
Procedure: Sleeve Gastrectomy with Transit Bipartition
Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in glycated hemoglobin (HbA1c)
Time Frame: 1 year
Complete diabetic remission (HbA1c < 6%) and partial diabetic remission (HbA1c= 6-6.5%) without medication.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension Control
Time Frame: 1 year
Systolic blood pressure (BP) <130 mm Hg and diastolic BP <80 mm Hg, without medication.
1 year
Change in LDL (low-density lipoprotein) Cholesterol
Time Frame: 1 year
<100 mg/dL, without medication.
1 year
Change in HDL (high-density lipoprotein) Cholesterol
Time Frame: 1 year
>40 mg/dL, without medication.
1 year
Change in Triglycerides
Time Frame: 1 year
<150 mg/dL, without medication.
1 year
Weight Control
Time Frame: 1 year
Amount of weight loss in kilograms.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Metabolic Surgery Foundation

Investigators

  • Principal Investigator: Alper Celik, MD, Turkish Metabolic Surgery Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/S01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Medical Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe