None listed
Conditions
Brief summary
A pilot study to assess the safety and tolerability of a 5:2 diet for obese persons with type 2 diabetes.
Interventions
A 12 week dietary intervention where participants fast (reduction to 25% of normal calorie intake) on 2 days each week. The group will be randomised so that half fast on consecutive days each and the other half may chose any 2 days to fast within each 7 day period. The participants will be provided with example meal plans for fasting days but no food is provided in this study. Diet diaries are to be used at the start and end of the study period. A pre-defined medication adjustment protocol w
A 12 week dietary intervention where participants fast (reduction to 25% of normal calorie intake) on 2 days each week. The group will be randomised so that half fast on consecutive days each and the other half may chose any 2 days to fast within each 7 day period. The participants will be provided with example meal plans for fasting days but no food is provided in this study. Diet diaries are to be used at the start and end of the study period. A pre-defined medication adjustment protocol will be used to adjust glucose lowering medications on fasting days.
Sponsors
Endocrine, diabetes and research centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
BMI 30 - 45 kg/m2 Type 2 diabetes treated with Metformin and/or a Sulphonylurea and/or insulin therapy HbA1c 64 – 86 mmol/mol
Exclusion criteria
Type 1 diabetes Known eating disorder Recent significant weight change (> 5 kg over past 3 months) Previous bariatric surgery Currently pregnant or planning pregnancy within 3 months Uncontrolled hypertension (180/100mmHg) Significant medical condition which, in the view of study investigators, would make recruitment in study inappropriate.
Outcome results
None listed