Effects of lowering blood glucose on T cell activation in fat tissue

ISRCTN	ISRCTN87451268
DOI	https://doi.org/10.1186/ISRCTN87451268
Secondary identifying numbers	15534

Submission date: 20/12/2013
Registration date: 20/12/2013
Last edited: 26/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Rebecca Travers
Scientific

Department for Health
Eastwood 22/23
The Avenue
Claverton Down
Bath
BA2 7AY
United Kingdom

Phone	+44 1225 386319
Email	R.L.Travers@bath.ac.uk

Study information

Study design	Non-randomised interventional and observational; Design type: Prevention, Cohort study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Effects of lowering blood glucose on T Lymphocyte activation in human adipose tissue
Study objectives	Overweight and obesity are major problems and their complications such as cardiovascular disease and type 2 diabetes mellitus (T2DM) pose great burdens on our healthcare systems. There is accumulating evidence to support obesity being a chronic inflammatory disorder mediated in part by expansion of adipose (fat) tissue (AT). In addition to adipocytes (fat cells), AT contains a range of other cell types including some immune (white blood) cells. Relative proportions of immune cell subpopulations and interactions between different cell types within AT may be important in the development of T2DM. We want to investigate some of the potential mechanisms leading to adipose tissue dysfunction and how the various cell types in adipose tissue contribute. In particular we are interested in the role of T lymphocytes since these cells are found in adipose tissue, but are normally involved in responses to infections. Our previous research has suggested that there may be important differences in the activation status of certain immune cells located in AT with increased overweight and further relationships with glucose and insulin sensitivity. Since insulin resistance and sensitivity can be rapid to respond to dieting and exercise, we would like to investigate whether immune cells present in subcutaneous adipose tissue may have a role in these early improvements in metabolic health. Our subjects will include metabolically healthy and unhealthy overweight individuals aged between 45-65 years who fit our criteria for inclusion. After taking some preliminary measurements and monitoring of normal daily activities, subjects will modify normal diet and activity for 10 days to reduce postprandial glucose and will attend 1 session of Laboratory testing before and 1 after this period which will take place in the Physiology Laboratories at the University of Bath. In this study we hope to learn more about the development of diseases associated with being overweight/obese.
Ethics approval(s)	13/SW/0267
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention	Diet and activity modification, For 10 days, participants will be instructed to consume a glucose lowering diet. This will involve modifications to their normal diet such as replacing high GI foods with lower GI foods. Participants will also be asked to incorporate some regular activity breaks throughout the 10 days. This involves participants going for a light 2 minute walk every 30 minutes to reduce sedentary time over a period of 8h per day for a total of 30 minutes extra activity per day. Study Entry : Registration only
Intervention type	Other
Primary outcome measure	T cell number and activation in adipose tissue; Timepoint(s): Pre and post intervention
Secondary outcome measures	1. Adipose tissue cytokine secretion; Timepoint(s): Pre and post intervention 2. Adipose tissue gene expression; Timepoint(s): Pre and post intervention 3. Macrophage number and activation in adipose tissue; Timepoint(s): Pre and post intervention 4. T Lymphocyte and monocyte numbers and activation in blood; Timepoint(s): Pre and post intervention
Overall study start date	06/01/2014
Completion date	01/08/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 22; UK Sample Size: 22; Description: 11 overweight/obese with normal glucose tolerance11 overweight/obese with impaired glucose tolerance
Key inclusion criteria	1. Male or postmenopausal* female 2. Aged between 45 to 65years 3. Waist circumference >94cm (males) or >80cm (females) 4. Weight stable for more than 3 months (no change in weight +/- 3%) Non-smoker Group 1 participants will be overweight with 'normal glucose tolerance' as defined by 2h oral glucose tolerance test (blood glucose <7.8 mmol/L at 2h post 75g glucose drink) Group 2 participants will be overweight with 'impaired glucose tolerance' (blood glucose >7.8 mmol/L but <11.1mmol/L at 2h post 75g glucose drink) *postmenopausal defined as no menstruation for at least 1 year (Witteman, Grobbee et al. 1989).; Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 45 years
Key exclusion criteria	1. Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia 2. Taking medications that may influence lipid or carbohydrate metabolism or immune system function 3. Perform >150minutes/week moderate intensity exercise
Date of first enrolment	06/01/2014
Date of final enrolment	01/08/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department for Health

Bath
BA2 7AY
United Kingdom

Sponsor information

University of Bath (UK)
University/education

The Avenue
Claverton Down
Bath
BA2 7AY
England
United Kingdom

"ROR"	https://ror.org/002h8g185

Funders

Funder type

Industry

BBSRC Industrial CASE Partnership Studentship with Unilever (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

No publications found in PubMed, verifying study status with principal investigator.