Effectiveness of a holistic intervention to address multimorbidity in adults with early-onset type 2 diabetes
- Conditions
- Type 2 diabetesNutritional, Metabolic, EndocrineType 2 diabetes mellitus
- Registration Number
- ISRCTN16890855
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 246
1. Age 16 to 45 years, inclusive
2. Type 2 diabetes diagnosed before the age of 40 years; confirmed by medical history with/without specialist investigations (e.g., antibodies)
3. HbA1c >= 6.0% (>= 42 mmol/mol) within 3 months of trial enrolment
4. Able to provide informed consent
1. Diagnosed with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes [MODY], gestational diabetes or latent autoimmune diabetes in adults [LADA])
2. Serious illness or event with life-expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement
3. Planned major surgery
4. Requirement for renal replacement therapy
5. Current pregnancy, or actively trying to conceive
6. Unable or unwilling to provide informed consent
7. Current participation in a competing clinical trial (CTIMP, as determined by the study investigator)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method