ISRCTN82062639
Completed
Phase 4
SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A randomised double-blind placebo-controlled trial (SEESAW)
niversity of Leicester0 sites68 target enrollmentJuly 20, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Specialty: Diabetes, Primary sub-specialty: Both
- Sponsor
- niversity of Leicester
- Enrollment
- 68
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35441435/ (added 26/10/2022)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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