The Effects of Reducing Prolonged Sitting Bouts in Individuals at High Risk of or With Type 2 Diabetes

NCT03482596 | Completed

• 1 other identifier: 0641
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Over 3 million in the United Kingdom are now diagnosed with type 2 diabetes, with current estimates suggesting this will rise to over 5 million by 2025. Type 2 diabetes increases the risk of developing cardiovascular disease, kidney disease, depression, neuropathy and dementia, along with being a leading cause of amputation and adult blindness. Sedentary behaviour, defined as any waking moment spend sitting or reclining with energy expenditure equal to or less than 1.5 METs, has emerged as a risk factor in the development of type 2 diabetes. Recent evidence has shown that breaking up prolonged sitting with regular short bouts of activity or standing lower postprandial glucose and insulin. However, the effectiveness of breaking prolonged sitting on glucose metabolism over a longer period of time is unknown. Therefore, the aim of this study is to investigate whether the reduction in postprandial plasma glucose in response to breaking prolonged sitting time is maintained following an intervention to reduce and break up prolonged sitting over a four to five week period. The study will be a single group intervention with pre and post randomised measurement conditions (prolonged sitting and light upright breaks) at both time points. A sample of 43 people (34 to complete), aged 50-75, identified as at risk of or with (drug naive) type 2 diabetes will be sought. The intervention will last approximately 5 weeks. Experimental conditions will be conducted before and after the intervention to assess whether reducing and breaking up prolonged sitting in free living effects glucose metabolism.

Conditions

Type 2 Diabetes Mellitus

Keywords

Sedentary Behaviour; Prevention

Outcome Measures

Primary Outcomes (1)

• Glucose incremental Area Under the Curve (iAUC)

  Glucose iAUC will be used to assess whether, following the intervention, the expected improvement in glucose metabolism is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.

  Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions

Secondary Outcomes (33)

• Insulin incremental Area Under the Curve (iAUC)

  Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions

• Triglycerides incremental Area Under the Curve (iAUC)

  Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions

• Blood pressure incremental Area Under the Curve (iAUC)

  Assessed prior to all 10 blood samples. This will be assessed for all of the 7.5 hour experimental treatment conditions

• Acylated ghrelin

  Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A

• Total PYY

  Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A

Study Arms (1)

Intervention

EXPERIMENTAL

All participants will follow the personalised multifaceted intervention to reducing/breaking prolonged sitting.

Behavioral: Reducing/breaking prolonged sitting

Interventions

Reducing/breaking prolonged sitting BEHAVIORAL

The participants will be encouraged to reduce prolonged sitting by at least 60 minutes per day by introducing light upright movement breaks spread throughout their day. The frequency and duration of these breaks will be tailored to each participant to suit their individual circumstances. The intervention will involve education regarding the health implications of prolonged sitting, personalised goal setting, behavioural feedback and self-monitoring of behaviour.

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Females may only be eligible if they are postmenopausal
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Postmenopausal Females.
• ≥ 40 to ≤ 75 years of age.
• And either:
• Overweight (White: BMI \> 25 - \<30, South Asian, Black or Chinese: \> 23 \<27.5) with HbA1c between 6.0 and 7.5%, within the previous 36 months).
• Obese (White: BMI ≥ 30, South Asian, Black or Chinese: ≥ 27.5).
• Large proportions of their day spent sitting (self-reported).
• Participant is willing and able to give informed consent to take part in the study.
• Not planning on altering their diet during the study.
• Able to walk without the use of an assistive device or requiring assistance form another person

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Reporting taking part in regular (at least once a week) sport of strenuous exercise.
• HbA1c \> 7.5%.
• Overweight with HbA1c \< 6.0%.
• Taking any glucose lowering therapies.
• Type 1 diabetes.
• Recent cardiovascular event (within the last 12 months).
• Female premenopausal.
• Current smoker.
• Terminal illness.
• Steroid use.
• Comorbidity that the research team consider to be a contraindication to involvement in the study
• Unable to communicate in English.
• Unable to provide written informed consent.

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• Loughborough University: collaborator
• Baker Heart and Diabetes Institute: collaborator

Study Sites (1)

Leicester Diabetes Centre

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: February 21, 2018
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

GB (1)