An observational study in Weight Loss, Diabetes Mellitus, Type 2 and Quality of Life, sponsored by Jose Seijas Amigo. Completed at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Jose Seijas Amigo · Observational
Introduction:
GLP-1 receptor agonists (aGLP1) act increasing pancreatic insulin secretion in response to the glucose, they reduce glucagon secretion and reduce appetite by acting in the central level. Several aGLP1 were approved through different clinical trials where they showed efficacy in the glycemic control and reduction in cardiovascular events. They also showed weight loss in different clinical trials with patients with diabetes mellitus 2 (DM2) and also in specific clinical trial where the weight loss was the primary endpoint (STEP study).
Objective:
The objective is to evaluate and compare the weight loss in patients with DM2 treated with the different aGLP1 for the first time. Secondary endpoints are HbA1c reduction, changes in quality of life and physical activity and the safety of these drugs.
Design:
It is a postauthorization, multicenter, non-randomized and prospective study. Patients that will start treatment for the first time with aGLP1 will be recruited in 10 primary care centers in SERGAS Galician Hospitals for a period of 6 months and 44 weeks of follow-up. The primary endpoint will be to evaluate the wight loss with the different aGLP1 and the secondary endpoint will be HbA1c reduction, changes in the quality of life through the EuroQol-5D and changes physical activity through the SF-12 questionnaire, and also the safety of these drugs. The sample size will be of 360 patients.
Statistical analysis:
Previous studies showed efficacy in weight loss with semaglutide about (3,6-4,9 kg), while with other aGLP1 the weight loss was smaller , about (0,86-2,96 kg).
Based in these data and with a 5% of significance level, a weight loss average in the aGLP1 group of 2,5 kg, average in semaglutide group of 4,2 kg, and combination deviation of 3,0kg, including 360 subjects we will have a statistical power above 90% to detect differences through T-test for independent samples.
The justification of this simple size was performed with the statistical software SPSS 3.0
Conclusions:
The SEVERAL study will try to provide information about weight loss efficacy, changes in quality of life, physical activity and safety of the aGLP1in patients with DM2 that start treatment with these drugs in the real life (Real-World Evidence)
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 140 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Jose Seijas Amigo is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with Diabetes mellitus 2 with another oral antidibetic and obesity (BMI > 30Kg/m2) that present uncontrolled HbA1c. With a first prescription of GLP-1 receptor agonists.
Exclusion Criteria:
Patients that meet criteria to start treatment with GLP-1 receptor agonists (dulaglutide; exenatide; liraglutide; lixisenatide )
Drug: GLP-1 receptor agonist
Patients are included after GLP1 agonists prescription , at the first dispensation
Weight loss
The primary outcome will be by assesment of % weight loss
Time frame: 11 months
Weight loss
Assesment the weiht loss by reduction in Kg
Time frame: 11 months
Weight loss
Assesment of changes in BMI ( weight (Kg) and height (cm) will be combined to report BMI in kg/m\^2)
Time frame: 11 months
HbA1c values
HbA1c changes will be assessed during the study by routine sample tests (%)
Time frame: 11 months
Changes in Quality of life
By using the questionnaire called EuroQol EQ-5D-3L assessment. It has 2 parts, the first one has 5 questions with 3 possible answers (5 dimensions and 3 levels), so each health status has a rate called EVA from 1,0000 (the highest value) to - 0,5095 (the worst health status). The second part is a visual self-assessment between 0 (the worst health status) and 100 (the best health status). https://euroqol.org/
Time frame: 11 months
Changes in Physical Activity
By using the questionnaire called EuroQol SF-12 assessment.For each of the 8 dimensions, the items are coded, added and transformed on a scale that ranges from 0 (the worst health status for that dimension) to 100 (the best health status).
Time frame: 11 months
Number of participants experiencing adverse events
Gastrointestinal events; hypoglycemia; pancreatitis; fatigue; ijection reactions; Diabetic retinopathy; cardiac events and other possible events
Time frame: 11 months
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Jose Seijas Amigo