VLCD & Adjuvant Exercise Effect in Overweight Diabetic Men

NCT04957589 | Completed

• 2 other identifiers: 19026_CMMP255016
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Muscle Protein Synthesis (MPS)

  Estimation via weekly sampling of saliva following deuterium oxide (D2O) tracer solution administration relative to baseline.

  6 weeks (throughout intervention)

• Muscle Protein Breakdown (MPB) (3MH)

  Estimation via peri-intervention study date measurement of serum and urine 3-methylhistidine (3MH) concentration relative to baseline.

  6 weeks (one day prior to intervention study dates in pre, peri and post periods)

Secondary Outcomes (17)

• Vascular function (femoral artery blood flow)

  6 weeks (pre and post intervention study dates only)

• Vascular function (contrast enhanced ultrasound scan)

  6 weeks (pre and post intervention study dates only)

• Vascular function (brachial artery reactive hyperaemia)

  6 weeks (pre and post intervention study dates only)

• Body composition (Dual-Energy X-ray Absorptiometry (DEXA) scan)

  6 weeks (pre and post intervention study dates only)

• Body composition (body weight measurement)

  6 weeks (pre and post intervention study dates only)

Study Arms (2)

VLCD & HIIT

EXPERIMENTAL

Very low calorie diet (standardised LighterLife meal replacement packages consisting of approximately 150kcal each, amounting to 600kcal/day, with 200kcal of a pre-determined free expenditure consisting of nuts and/or vegetables) High intensity interval training (3x sessions per week following intensity estimation using cardiorespiratory testing (VO2max), using an established training protocol within our department) No additional protein supplementation

Dietary Supplement: Very Low Calorie Diet; Other: High Intensity Interval Training

VLCD only

ACTIVE COMPARATOR

Very low calorie diet (standardised LighterLife meal replacement packages consisting of approximately 150kcal each, amounting to 600kcal/day, with 200kcal of a pre-determined free expenditure consisting of nuts and/or vegetables) No additional exercise or protein supplementation

Dietary Supplement: Very Low Calorie Diet

Interventions

Very Low Calorie Diet DIETARY_SUPPLEMENT

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.

Also known as: LighterLife®, Very Low Energy Diet, Calorie Restriction, Caloric Restriction

VLCD & HIIT; VLCD only

High Intensity Interval Training OTHER

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.

Also known as: HIIT, Home HIIT

VLCD & HIIT

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to provide informed consent.
• Adult patients between the age of 30-65 years
• A body mass index (BMI) of between 27-50
• Confirmed Type 2 Diabetes Mellitus (T2DM)

You may not qualify if:

• contrast (Sonovue) sensitivity,
• known renal, musculoskeletal, neurological, bowel, cardiovascular, respiratory or cerebrovascular disease,
• or current/recent formal exercise regime participation (within two years).
• Prospective volunteers with a weight exceeding 120kg are ineligible to participate due to the weight restriction present in the DEXA machine.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Interventions

Caloric Restriction; High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Iskandar Idris, BMBS FRCP DM

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is infeasible, as the participants will know which intervention they are partaking in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a proof-of-concept, single centre, randomised, non-blinded control trial.

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: July 12, 2021
• Study Start: January 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)