Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Participants will be invited via newspaper advertisement (n=24). After a full explanation of the study, written consent will be requested.
Tests will be carried out at baseline, durin
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented type 2 diabetes of duration less than 6 years (same as DiRECT) 2. All ethinicities 3. BMI of 21-27 kg/m2 for people of Caucasian ethnicity and 19-27 kg/m2 for people of other ethnicity due to documented differing metabolic risks per BMI unit
Exclusion criteria
Exclusion criteria: 1. Current insulin use 2. HbA1c > = 12% 3. Substance abuse 4. Known cancer 5. Myocardial infarction within previous 6 months 6. Learning difficulties 7. Diagnosed eating disorder or purging 8. Pregnant or considering pregnancy 9. Previous hospitalisation for depression 10. Presence of metal implants preventing magnetic resonance scanning 11. Claustrophobia likely to cause discomfort in the MR scanner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c and plasma glucose at baseline, 8 weeks, 16 weeks, and 52 weeks will be measured using HPLC (Tosoh Bioscience, UK) and oxidase method (Yellow Springs Inc., USA), by the Clinical Pathology Accreditation Laboratory (Newcastle upon Tyne Hospital NHS Foundation Trust, UK). An HbA1c under 48mmol/l is used to establish remission of type 2 diabetes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Markers of adipose tissue overexpansion as potential guides to defining a Personal Fat Threshold during the weight loss phase. This includes: 1.1. Blood total lipid profile: (fasting plasma and taken up to 3h after standard meal test) are measured at baseline, after each weight loss phase (at 8 weeks, 16 weeks, and at 24 weeks if a 3rd weight loss cycle is required) and at 52 weeks by Clinical Pathology Accreditation Laboratory (Newcastle upon Tyne Hospital NHS Foundation Trust, UK) 1.2. Blood lipoprotein profile: Chylomicrons, VLDL1, VLDL2, and LDL will be separated from plasma at the same timepoints as above using is MX 150+ ultracentrifuge and S140-AT rotor (Thermo Scientific, Germany). Triglyceride level will be measured for each lipoprotein fraction using standard method (Roche Diagnostics, UK). 1.3. Inflammation markers and hormones: plasminogen activator inhibitor-1, C-reactive protein, TNFa, interleukin 6), adiponectin and leptin will be measured in house using commercially available kits (ELISA) at the baseline of the study and following each cycle of weight loss. 2. Pancreatic fat content and morphology during the weight loss phase, measured by magnetic resonance using in house developed methods (MR-opsy). This will be performed at baseline, 8 weeks, 16 weeks and 52 weeks. If a 3rd cycle of weight loss is required then a further scan will be done at 24 weeks. For normal glucose tolerance group, this will be carried out at one timepoint only. Pancreas volume will be measured using volume rendering technique of the acquired magnetic resonance images following the same time course. 3. Fatty acid composition of fasting plasma and lipoprotein fraction determined using standard FAME analysis by GC-MS (Thermo Scientific, Waltham, MA) at baseline, during and after restriction of food energy 4. Achievement and maintenance of weight loss target, choice of dietary strat | — |
Countries
England, United Kingdom
Outcome results
None listed