Long-Term Maintenance of Type2 Diabetes Remission in Real-World v1
Research type
Research Study
Full title
Long Term Maintenance of Type 2 Diabetes Mellitus Remission using Low-Carbohydrate Diet in Real-World: A Mixed-Methods Study
IRAS ID
317072
Contact name
Ayse Nur Aksoy
Contact email
Sponsor organisation
Edge Hill University
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Remission of type 2 diabetes (T2DM) is defined as having normal HbA1c (three-month average of blood glucose) levels below than diagnostic level (48 mmol/mol) and being off diabetes drugs for at least 3 months. Remission of T2DM is now found to be feasible and can be achieved through significant weight loss and maintenance of weight loss. Low-Carbohydrate diets (LCDs) are shown to be effective in remission for some patients. Currently, there is no study which looked at how patients maintain remission in a real-world setting and what experiences do they get in a 6 month period who have used LCD.
The Study 1 will focus on newly T2DM remission induced patients recruited from GP practices who implement LCD in their patients. Participants will be enrolled into the study with baseline measurements being recorded. These include bodyweight, diet, physical activity levels, quality-of-life and biochemical tests (HbA1c, blood lipids, blood pressure and liver function enzymes). Biochemical measurements and weight will be taken at their GP clinics as part of their routine care. The only measures that the study will ask participants to complete are the 4-day food diaries, quality-of-life and physical activity questionnaires. At 2-3 and 6 months, these measurements will be collected again. To evaluate individuals’ experience on their remission, virtual/telephone semi-structured interviews will be conducted at baseline and 6 months.
Study 2 will focus on understanding healthcare professionals’ experience and perceptions on T2DM remission in those who are actively working in T2DM remission. These will be explored during interviews (to be conducted once) and will be outside of the main study schedule. It should help to understand their perceptions and support regarding T2DM remission given that their support to patients is important and this may help to inform health care and how best help patients with T2DM who are in remission.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0451
Date of REC Opinion
15 Dec 2022
REC opinion
Further Information Favourable Opinion