TMSF announces initiation of HIPER-1 Study
Obesity and type 2 diabetes are increasing in prevalence worldwide, to such proportions that it can only be described as an epidemic. Medication and life style changes which include diet and exercise remain as the cornerstones of type 2 diabetes treatment. However; the long-term success rates of lifestyle and drug modifications are disappointing. Despite an impressive array of pharmacotherapeutics, adequate long-term glycemic control is difficult. Besides, diabetes medication can promote weight gain, which in turn introduce obesity issues.
The fact that classic strategies prove to be inadequate caused surgical treatment options to appear as alternative treatment methods. Surgical procedures offer a new alternative to treat obesity and type 2 diabetes. Among severely obese patients, bariatric surgical options cause significant sustained weight loss, improve obesity-related co-morbidities, and reduction in long-term mortality. Currently, bariatric surgery is advised to individuals with a body mass index (BMI) >35 kg/m2 and serious obesity-related comorbidities, including type 2 diabetes. Operations involving intestinal bypasses prove to be particularly more effective on diabetes. Mounting evidence indicates that these remarkable effects result not only from weight loss but also from weight-independent anti-diabetic mechanisms. Consequently, conventional bariatric procedures and novel gastrointestinal operations are being explored for the management of patients with type 2 diabetes and are overweight or class I obese (BMI: 30-35 kg/m2). However, one question remains: What are these weight-independent anti-diabetic mechanisms? This question has not been fully answered, until now.
HIPER-1 (Human Intestinal Peptides Evaluation & Research) study is the first step in a series of studies that aim to answer this question, along with many more related questions as well. The study has been initiated by Turkish Metabolic Surgery Foundation (TMSF) and Dr Alper Celik, head of HIPER-1 study and President of Turkish Metabolic Surgery Foundation, has explained the details of HIPER-1 study only for Bariatric News.
Dr Alper Celik reminded that various physiological mechanisms proposed to explain the improvement of glucose metabolism, insulin metabolism and beta-cell function following surgery but the complete mechanisms remained poorly understood. He continued his words with the following:
HIPER-1 will be a cross-sectional study. There will be 2 groups: Non-surgical and surgical group. Both of these groups will have 4 sub-groups each, which are: Healthy subjects (sub-group 1), diabetic obese (sub-group 2) , diabetic non-obese (sub-group 3), obese non-diabetics (sub-group 4) for non-surgical group and for surgical group: Patients who underwent either sleeve gastrectomy (sub-group 5), mini gastric bypass (sub-group 6), sleeve gastrectomy with ileal transposition (sub-group 7), and sleeve gastrectomy with transit bipartition (sub-group 8). In HIPER-1 study, we aim to analyze the baseline levels and 30-60-120 minutes post-prandial activities of GLP-1 and Peptide YY in non-surgical and surgical groups. We have 3 main goals:
To measure and compare levels of GLP-1 and Peptide YY in non-obese healthy volunteers vs. obese diabetics vs. obese non-diabetics vs. non-obese diabetics after administration of OMTT at baseline and 30-60-120 minutes.
To measure and compare levels of GLP-1 and Peptide YY in patients who have undergone Sleeve Gastrectomy (SG) or Mini-Gastric Bypass (MGB) vs. Sleeve Gastrectomy with Ileal Transposition (SIT) vs. Sleeve Gastrectomy with Transit Bipartition (STB) after administration of OMTT at baseline and 30-60-120 minutes.
To analyze the response of the insulin and glucose following the OMTT in relation to the type of surgery.
Of course, this will just be the initial evaluation of a durability study that is planned for a minimum of 5 years follow up, so these goals are just the beginning. We can never be sure of what we might uncover in the end. I do believe, however, that the results of HIPER-1 study can change everything about what we know regarding metabolic surgery.’’
Lastly, Dr. Alper stated that the study had been registered in Clinical Trials, and if all goes well, they hope to start the study by the second week of October 2015.