Status:
TERMINATED
SAFE-LCD Trial, for Insulin-treated Adults Living With Type 2 Diabetes
Lead Sponsor:
Oviva UK Ltd
Collaborating Sponsors:
Hull University Teaching Hospitals NHS Trust
University College, London
Conditions:
Type 2 Diabetes Treated With Insulin
Diet Habit
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
SAFE-LCD study is a randomised controlled trial aiming to develop and evaluate a safe, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type ...
Detailed Description
Insulin treatment in Type 2 diabetes (T2D) patients is linked to poorer quality of life and and increased risk of complications due to disease progression. This research study will be a randomised co...
Eligibility Criteria
Inclusion
- Registered with a GP practice within the confirmed NHS site - Humber and North Yorkshire
- Diagnosis of type 2 diabetes treated with insulin
- Age 18-70 years inclusive
- BMI ≥30kg/m² (adjusted to ≥27 kg/m² in ethnic minority groups)
- Upper body weight limit of 180kg (if using BodyTrace scales)
- Ability to speak, read and receive care in English language
- Access to the internet and a personal email address
- Access to and ability to use a smartphone
- Willing to test blood glucose up to 7 times a day (for up to 4 months) to ensure clinical safety.
- Participants capable to provide written informed consent and willing to comply with the trial protocol
Exclusion
- C-peptide \<200 pmol/L AND positive Glutamic Acid Decarboxylase(GAD) antibodies assessing for misdiagnosed Type 1 diabetes and risk of diabetic ketoacidosis.
- Type 1 diabetes mellitus, Mitochondrial diabetes, Maturity-Onset Diabetes of the Young (MODY) diabetes or diagnostic uncertainty (e.g. dual codes on patient record) Type 2 diabetes with history of diabetic ketoacidosis (DKA) or ketosis prone
- Clinically assessed hypoglycemia unawareness (via GOLD score (11, 12))
- Concomitant medication use clinically deemed to affect metabolic rate and body weight
- A major cardiovascular event within 6 months
- Severe angina, uncontrolled arrhythmia or known prolonged QT syndrome
- Warfarin or Rivaroxoban therapy
- Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m²
- A condition precipitating fluid overload (e.g. New York Heart Association class III-IV congestive heart failure)
- Active liver disease (except non-alcoholic fatty liver disease (NAFLD)
- Active gallstone disease or known presence of gallstones
- Active cancer, receiving cancer treatment or received cancer treatment within past 24 months
- Known proliferative retinopathy that has not been treated
- Uncontrolled epilepsy
- Uncontrolled thyroid dysfunction
- Active or suspected peptic ulcer disease
- Gout
- History of bariatric surgery (previous band/balloon allowed if removed\<12 months)
- Clinically diagnosed with an active eating disorder
- Clinically significant diagnosed/self-reported psychiatric disease that may interfere with study compliance
- Known or suspected alcohol or recreational drug misuse
- Milk allergy (Nualtra, TDR allergens)
- Soya allergy (Nualtra, TDR allergens)
- Vegan (Nualtra, animal derived Vit D)
- Pregnancy or planning pregnancy within study period
- Lactating
- Currently on a weight management programme or had in last 3 months or had over 5% weight loss in previous 6 months
- Current participation in other clinical intervention trials
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06119204
Start Date
January 26 2024
End Date
September 9 2024
Last Update
October 15 2024
Active Locations (1)
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1
Hull University Teaching Hospital NHS Trust
Hull, United Kingdom, HU3 2JZ