VLCD & Adjuvant Exercise Effect in Overweight Diabetic Men

Summary

Sarcopenia is defined as the incremental age-related loss of skeletal muscle in humans which generally begins from forty years old. It is associated with an overall reduction in quality of life and increased morbidity and mortality. Patients with type two diabetes mellitus (T2DM) are particularly at risk of developing sarcopenia, partly due to the condition and also due to the common incidence after or during middle age. A promising recently-investigated and effective conservative approach to T2DM is through very low calorie diets (VLCD). Some studies have shown that the diabetic status of some patients can be reversed through VLCD. However, VLCD will theoretically result in an acceleration of sarcopenia. This presents as a limiting factor for the implementation of VLCD in this at-risk patient group. Skeletal muscle tissue is encouraged to grow in size or be maintained through two means - an increase in circulating protein breakdown products, or through resistance exercise (RE). Additionally, RE has been shown to increase the body's sensitivity to insulin, the main hormone which controls circulating glucose levels and is frequently impaired in T2DM, as well as temporarily decreasing glucose levels. The precise mechanism by which these happen is not fully understood yet. In this study, the effect of a VLCD is used, alongside one form of exercise (high intensity interval training, HIT), in overweight, middle-aged male patients with T2DM. 10 patients are to be recruited into each group (control/VLCD-only and VLCD with HIT) at our centre. Patient weight, markers of muscle protein synthesis, glucose levels and changes to blood vessels will be investigated before, during and after across a six week timeframe. Investigations will include muscle and fat biopsies, blood samples, ultrasound scans, strength testing and deuterium oxide (D2O) isotope ingestion for later non-invasive body fluid sample mass spectrometric analysis.

Conditions

• Diabetes Mellitus Type 2 in Obese

Interventions

DIETARY_SUPPLEMENT

Very Low Calorie Diet

A dietary intervention consisting of four meals (provided by LighterLife®), totaling approximately 600kcal/day (each meal comprising approximately 150kcal/day). Participants are provided with a choice of one of six "meal protocols", which consist of a pre-set combination of meals that arrive at approximately 52g protein, more than 15g fibre and less than 20g sugar per day.

OTHER

High Intensity Interval Training

The HIIT training will consist of a five-exercise approach across three movements (star jumps, standing squats, on-the-spot-sprinting, standing squats and star jumps), which are collectively described as a cycle in this context. Each exercise is performed for 60 seconds with a 90 seconds recovery period. Each training session will begin with a two minute warm-up and cooldown (on-the-spot-jogging) followed by five minutes of static stretching. Volunteers would aim to exceed the initial number of star jumps and standing squats in the subsequent attempt per cycle. A total of three training sessions per week are to be completed, preferably non-consecutive but may be consecutive on no more than two training sessions per week. Progression is through a gradual increase in volume (repetitions of star jumps and standing squats) on a per-session basis.

Sponsors & Collaborators

• University of Nottingham

  lead OTHER

Principal Investigators

• Iskandar Idris, BMBS FRCP DM · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2022-12-01

Completion

2022-12-01

Countries

• United Kingdom

Study Locations