A Diabetes Improvement in Medical Therapy Versus SADJB Study

NCT03165812 | Unknown DMC

• 1 other identifier: NMRR-16-1486-32126
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

The incidence of diabetes mellitus is increasing annually in Asia. It is the leading cause of blindness, chronic renal insufficiency, and amputations, multiplying the risks of heart disease and stroke. Ninety percent of diabetic patients are type 2 diabetes mellitus (T2DM), which is usually associated with overweight and obese. Single Anastomosis Duodeno-Jejunal Bypass with Sleeve Gastrectomy (SADJB-SG) is a type of bariatric surgery whereby food is bypassed into the distal jejunum, and the duodenum is excluded. Sleeve gastrectomy offers the restrictive component by reducing the capacity of the stomach. In short, this combined technique results in food restriction and malabsorption. A total of 84 patients will be recruited in this study. An equal number of patients will be allocated into two groups. There will be an intensive medical therapy group (IMT) and SADJB-SG group. The patients in IMT group will be subjected to strict adherence to diet, optimization of diabetic medications and close monitoring of blood glucose and glycated haemoglobin (HbA1c) level. The SADJB-SG group will be undergoing surgery. The variables that will be studied include body mass index (BMI), fasting blood glucose (FBG), glycated haemoglobin (HbA1c), C- peptide, plasma insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Biochemical markers are important in this research as the development of T2DM involves both multi-organ insulin resistance and inadequate insulin secretion by pancreatic β-cells, leading to high blood sugar during fasting and post meal. Other mechanisms proposed in this study are leptin, adipokines, incretins, amino acids, and diabetic dyslipidaemia. The raw data will be analysed using the SPSS statistical software. At the end of the study, the investigator will evaluate and determine the role of SADJB-SG in glycaemic control and BMI in T2DM patients compared to IMT. The investigator hypothesized that there is an improvement in HbA1c level in T2DM patients in SADJB-SG group compare to IMT group.

Conditions

Diabetes Mellitus, Type 2; Overweight

Keywords

Sleeve Gastrectomy; Duodeno Jejunal Bypass; Single Anastomosis; Intensive Medical Therapy; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Type 2 Diabetes Mellitus (T2DM) patients in SADJB-SG group achieving glycated hemoglobin (HbA1c) level of less than 7% (with or without diabetes medications) in 2 years as compare to patients in IMT group.

  The HbA1c level is measured in percentage

  24 months

Secondary Outcomes (6)

• T2DM patients in SADJB-SG group achieving mean fasting blood glucose level of 4.4-7.0 mmol/l in 2 years as compare to patients in IMT group.

  24 months

• T2DM patients in SADJB-SG group achieving lower body mass index (BMI) in 2 years as compare to IMT group.

  24 months

• Changes in serum level of lipids.

  24 months

• Assessment of NAFLD associated morbidities by detecting the metabolic changes after SADJB-SG.

  24 months

• Identification of proposed mechanism for improvement in glycemic control following SADJB-SG.

  24 months

Study Arms (2)

SADJB-SG group

EXPERIMENTAL

Patients in this group will undergo bariatric surgery. There are two parts to this procedure. One is the restrictive type of weight loss surgery, which reduces the stomach size. The other type prevents the body from absorbing fats and sugar properly, as the small intestine will be attached to the small stomach, bypassing most of the stomach and upper part of the small intestine. This surgery will be performed using a minimally invasive technique known as laparoscopic keyhole surgery.

Procedure: SADJB-SG group

IMT group

EXPERIMENTAL

Patients in this group will be subjected to strict adherence to diet, optimisation of diabetic medications and close monitoring of blood glucose and HbA1c.

Procedure: IMT group

Interventions

SADJB-SG group PROCEDURE

Patients will undergo bariatric surgery. A clear liquid high protein diet will be started in the first two postoperative days. If no complications were detected by physical examination, patients will be stimulated to walk and will be dismissed from the hospital on postoperative day 3. Patients will be subjected to a strict adherence to diet and close monitoring of their blood glucose and HbA1c levels during the study period. Standard follow-up includes a visit to the outpatient clinic at 1, 2, 3, 4 weeks after surgery, then 3, 6, 9, 12, 18, 24 months and after that, a life-long annual visit. Glycaemic control at home will be maintained as in the preoperative period and patients will need to inform the results of their blood glucose levels to the doctor during each follow-up visits.

SADJB-SG group

IMT group PROCEDURE

Patients will be subjected to strict adherence to their diet, optimisation of their diabetic medications and close monitoring of their blood glucose and HbA1c levels at 0, 6, 12, 24 months. The endocrinologist will be monitoring the patients in this group. Detailed individualized lifestyle and dietary counseling will be given by a dietitian emphasizing on nutrition knowledge, the timing of meal with medication, portion control, and increasing daily physical activity level.

IMT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years.
• BMI 23.5 - 30 kg/m2.
• Diabetes more than two years and less than ten years.
• American Society of Anesthesiologists (ASA) classification \< 4
• Able to give informed consent

You may not qualify if:

• Age: below 18 and above 65.
• Inability to informed consent.
• Patients on GLP-1 agonist and insulin two weeks before admission into the trial.
• Diabetes more than ten years or less than two years.
• C-Peptide level \< 2.0 ng/mL
• American Society of Anesthesiologists (ASA) classification \> 3
• Logistic issue where patient come from rural area and has difficulty in complying with the post-operation close monitoring and follow-up
• Patient who has psychiatric disorder (depression, substance abuse, eating disorder, alcoholism, dementia etc.)

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (2)

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

RECRUITING

Hospital Serdang

Kajang, Selangor, 43400, Malaysia

RECRUITING

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tikfu Gee, MBBS, MS

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tikfu Gee, MBBS, MS

CONTACT

+6018 984 2300; groupesantesoin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer/ consultant

Model Details: The study will involve two groups with equal allocation of patients in the intensive medical therapy (IMT) group and Single Anastomosis Duodeno Jejunal Bypass with Sleeve Gastrectomy (SADJB-SG) group with stratification by use of insulin at screening. All patients who agree to participate in this study will be assigned to one of the treatment groups by the doctor without randomization.

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 24, 2017
• Study Start: April 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)