The effects of empagliflozin on appetite and weight regulation in diabetics

Phase 4

Completed

• Conditions: Specialty: Diabetes, Primary sub-specialty: Both; UKCRC code/ Disease: Metabolic/ Diabetes mellitus, Metabolic/ Diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN82062639
• Lead Sponsor: niversity of Leicester

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35441435/ (added 26/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-20
• Study Completion: 2019-07-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Male and postmenopausal female participants aged between 30-70 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 (6.5 - 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 >70 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Peptide Y-Y (PYY) concentration in blood samples is measured 8 times per visit at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Ghrelin and GLP-1 concentration in blood samples is measured 8 times per visit at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks<br> 2. 2. Weight and body composition is measured by DEXA scanning at baseline and 24 weeks<br> 3. Resting energy expenditure is measured using indirect calorimetry at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks<br> 4. Physical activity is measured using physical activity monitors at the familiarisation visit and at 6 weeks, 12 weeks and 24 weeks<br> 5. Full Blood Count, Urea & Electrolytes, Liver Function Test, lipids, HbA1c, C-Reactive Protein, Urine Glucose Excretion, Fasting Plasma Glucose, Free Fatty Acids will be measured once per visit at the familiarisation visit and at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks<br> 6. Insulin, glucose, glucagon and leptin will be measured 8 times per visit 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks<br>