Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Participants will randomly consume either a small dose (15g) of whey protein (Arla Foods Ingredients Group P/S., [AFI], Denmark) or a protein-depleted placebo supplement (AFI, Denmark) 10 minutes befo
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 2 diabetes mellitus for at least 1 year prior to participation in this trial. 2. Treated with either lifestyle modifications and/or oral medications, which have been stable for 3 months or more. 3. Weight stable for 1 month or more (i.e. weight has not fluctuated by more than 1kg prior to study enrolment). 4. HbA1c of below 9.5% (80mmol/mol) 5. Aged between 30-68 years of age 6. Regularly consume breakfast 7. Adhere to a normal sleep/wake cycle
Exclusion criteria
Exclusion criteria: 1. Treated with insulin or incretin mimetic therapies. 2. History of severe cardiovascular events, renal failure or liver disease within the last 12 months. 3. Gastrointestinal issues. 4. Known food intolerance's or allergies. 5. Substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glycaemic responses (incremental area under the curve) to patient’s free-living main meals (breakfast, lunch and dinner) following prior consumption of the protein-rich and protein-depleted supplement (i.e. “pre-load”). Glycaemic responses will be measured from interstitial glucose concentrations collected from patient's continuous glucose monitoring system (CGM) over a 7-day free-living period, where a postprandial period will be defined as an uninterrupted 2-hour phase following commencement of a reported meal. Postprandial glycaemic responses will be calculated using the trapezoidal rule. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Energy intake (kcal) measured by an ad libitum lunch meal served during the mixed meal tolerance tests [visits 2, 3, 5 and 6]. Energy intake will be calculated from weighing both served and unserved amounts of the test meal, and before and after meal consumption. 2. Time-course changes in subjective appetite sensations measured using a linear visual analogue scale during the mixed meal tolerance tests [visits 2, 3, 5 and 6]. 3. Time-course responses in blood glucose, insulin, lipids and gut hormones following a standardised mixed-nutrient breakfast meal prior to and immediately following the 7 day period. All markers will be analysed by routinely available assays [mixed meal tolerance tests: visits 2, 3, 5 and 6]. 4. Changes in pro-inflammatory cytokine concentrations (interleukin-6, tumour necrosis factor alpha and high-sensitivity C-reactive protein) following 7-days of supplementation. Pro-inflammatory cytokine concentrations will be measured from a fasting blood sample collected during the mixed-meal tolerance tests measured by routinely available assays [mixed meal tolerance tests: visits 2, 3, 5 and 6]. 5. Patient experiences and attitudes towards consuming a nutrient pre-load as a mode to treating their diabetes as analysed by a patient interview conducted at the end of the trial [visit 6]. Interviews will be transcribed into a written format and analysed for themes. 6. Markers of free-living glycaemic variability (MAGE, M-Value, SD and CONGA) will be calculated from interstitial glucose concentrations measured from a CGM over a 7-day free-living period using EasyGV V9.0.R2 (Oxford University, UK). Circulating concentrations of 1, 5-anhydroglucitol collected from fasting blood samples during the mixed-meal tolerance tests will be measured by routinely available assays [visits 2, 3, 5 and 6]. 7. Time spent in hypoglycaemia ( 13.9 mmol/L) during a 7-day free-living period as measured from interstitial glucose concentrations reported from the CGM. Time spent | — |
Countries
England, United Kingdom
Contacts
Public ContactDaniel;Kieran West;Smith
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Outcome results
None listed