Contact information
Type
Scientific
Primary contact
Miss Rebecca Travers
ORCID ID
Contact details
Department for Health
Eastwood 22/23
The Avenue
Claverton Down
Bath
BA2 7AY
United Kingdom
+44 1225 386319
R.L.Travers@bath.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15534
Study information
Scientific title
Effects of lowering blood glucose on T Lymphocyte activation in human adipose tissue
Acronym
Study hypothesis
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
13/SW/0267
Study design
Non-randomised interventional and observational; Design type: Prevention, Cohort study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
06/01/2014
Overall trial end date
01/08/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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
Participant 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
Recruitment start date
06/01/2014
Recruitment end date
01/08/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department for Health
Bath
BA2 7AY
United Kingdom
Funders
Funder type
Industry
Funder name
BBSRC Industrial CASE Partnership Studentship with Unilever (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary