Diabetes Mellitus, Type 2 Clinical Trial
— SEESAWOfficial title:
SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)
NCT number | NCT02798744 |
Other study ID # | 0526 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | July 30, 2019 |
Verified date | January 2020 |
Source | University of Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the cause for the discrepancy in predicted and
observed weight loss with Empagliflozin (Jardiance™) by measuring appetite regulation.
Major secondary objectives are to determine the effects of Empagliflozin (Jardiance™) on
energy expenditure and change in total body weight and body composition.
The primary outcome is change in appetite hormone concentrations (specifically total PYY)
between baseline and 24 weeks: - this will be measured by sequential blood sampling during
visits 1-5.
Secondary outcomes, which are exploratory, are effect on appetite hormones (ghrelin and
GLP-1), appetite perceptions, total body weight and fat and fat free mass, energy
expenditure, appetite perception, physical activity and blood and urine biochemical
parameters after Empagliflozin (Jardiance™) treatment for 24 weeks.
The sample size for the study is 76 participants and the planned trial duration is 21 months,
with participants receiving approximately 24 weeks of exposure to Empagliflozin (Jardiance™).
Status | Completed |
Enrollment | 68 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria 1. Male and postmenopausal female participants aged between 30-75 years of age inclusive 2. Type 2 diabetes on diet and lifestyle control or stable dose of metformin only for at least 3 months 3. Stable weight (less than 5% change in body weight in last 3 months) - determined by self-reporting or documentation in clinical records 4. HbA1c 48-86mmol/mol (6.0 - 10%) 5. eGFR=60ml/min/1.73m2 6. BMI = 25kg/m2 7. Able and willing to give informed consent 8. Able to understand English Exclusion Criteria 1. Females who are not postmenopausal (as menstrual cycle can affect appetite hormone concentrations) which is defined as "2 years post last menstrual period <50 years of age or 1 year post last menstrual period >50 years of age." 2. Type 2 diabetes on any other glucose lowering treatment except metformin 3. Patients with Type 1 diabetes 4. Patients on loop diuretics 5. Age <30 years and >75 years 6. BMI <25kg/m2 7. Not able to give informed consent 8. Not able to understand English 9. Moderate to severe renal impairment (eGFR<60ml/min/1.73m2) 10. Unstable diabetes i.e. HbA1c >86mmol/mol (10%), recent hospital admission with diabetic emergency in last 3 months 11. Patients with familial renal glycosuria 12. Patients with recurrent balanitis, vaginal or urinary tract infections 13. Shift workers 14. Patients who have participated in another study of an investigational medicinal product in the last 3 months 15. Active malignancy 16. Serious illness with a life-expectancy of less than 1 year 17. Hypersensitivity to Empagliflozin (Jardiance™) or to any of the excipients 18. Patients with latent autoimmune diabetes in adults (LADA) 19. Patients with a history of chronic pancreatitis 20. Evidence of conditions that lead to restricted food intake or severe dehydration 21. Patients with a history of excessive alcohol consumption 22. Patients on a severely calorie restricted diet (i.e., =800 calories per day) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leicester Diabetes Centre | Leicester |
Lead Sponsor | Collaborator |
---|---|
University of Leicester | Loughborough University, University Hospitals, Leicester |
United Kingdom,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Total PYY at 24 weeks | The effect of Empagliflozin on appetite hormone 'Total PYY' concentration between baseline and 24 weeks. Measured by sequential blood sampling at study visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in Ghrelin at 24 weeks | Change in appetite hormone 'Ghrelin' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in GLP-1 to 24 weeks | Change in appetite hormone 'GLP-1' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in appetite perceptions to 24 weeks | Change in appetite perceptions from baseline to 24 weeks. Measured by questionnaires visits 1 -5. | Baseline and 24 weeks | |
Secondary | Change in Weight (kg) from baseline to 24 weeks | Change in weight (kg) from baseline to study end and between groups. This will be measured at visits 1 - 5. | Baseline and 24 weeks | |
Secondary | Change in Body composition from baseline to 24 weeks | Change in body composition from baseline to study end and between groups. This will be measured by Dual Energy X-Ray Absorptiometry (DEXA) scanning at visits 1 and 5. | Baseline and 24 weeks | |
Secondary | Change in resting energy expenditure from baseline to 24 weeks | Change in resting energy expenditure from baseline to study end and between groups. This will be measured by indirect calorimetry at visits 1-5. | Baseline and 24 weeks | |
Secondary | Change in objectively measured Physical Activity from baseline to 24 weeks using activity monitors | Change in physical activity from baseline to study end and between groups. This will be measured using physical activity monitors at visits 0, 3, 4 and 5. | Baseline and 24 weeks | |
Secondary | Change in subjectively measured Physical Activity from baseline to 24 weeks using the International Physical Activity Questionnaire (IPAQ) | Change in physical activity from baseline to study end and between groups. This will be measured using the international physical activity questionnaire at visits 1 - 5. | Baseline and 24 weeks | |
Secondary | Change from baseline urine glucose excretion to 24 weeks. | Change in urine glucose excretion to study end and between groups. This will be measured using urine sampling at visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in blood appetite hormones to 24 weeks | Change in in baseline blood appetite hormones to 24 weeks between groups. This will be measured using blood sampling at visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in HbA1c to 24 weeks | Change in in baseline HbA1c to 24 weeks between groups. This will be measured using blood sampling at visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in inflammatory markers to 24 weeks | Change in in baseline inflammatory markers to 24 weeks between groups. This will be measured using blood sampling at visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in renal functioning to 24 weeks | Change in in baseline renal functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5. | Baseline and 24 weeks | |
Secondary | Change from baseline in liver functioning to 24 weeks | Change in in baseline liver functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5. | Baseline and 24 weeks |
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