NCT03362554Active, not recruiting
Identification of New Biomarkers of Insulin Resistance
Source: ClinicalTrials.gov · Last updated 28 Nov 2023
Brief summary (registry, in English)
Diabetes is a chronic metabolic disease affecting 415 million people worldwide, 90% of cases are type 2 which is frequently associated with obesity and a sedentary lifestyle. In healthy individuals, insulin stimulates increased cell surface expression of a glucose transporter (GLUT4) in muscle and fat tissue. This prevents blood sugar levels becoming dangerously high by taking sugar into the muscle and fat cells. Loss of this response ('insulin resistance') frequently occurs before the development of type 2 diabetes. Understanding the cell biology of insulin resistance is necessary to develop more effective treatments for this condition and prevent further cases of type 2 diabetes. Previous work showed that this movement of GLUT4 is dependent on a small protein called Rab3 which is downregulated in insulin resistance. Rab3 protein levels are also sensitive to inflammation, a state that is exacerbated by obesity. In order to examine whether Rab3 is an early biomarker of insulin resistance, we aim to measure the levels of this protein and its interactors in fat and muscle samples from insulin resistant individuals. It has been shown that insulin sensitivity can be improved with an intervention as short as three weeks when net energy intake is sufficiently reduced. Therefore, by taking the same measurements before and after this three week intervention we can observe any improvements in Rab3 expression and insulin sensitivity at a cellular level. There is also evidence for an effect of the gut microbiome on insulin sensitivity so we will measure any changes that take place in the gut microbiome following this intervention, which can be determined from faecal samples taken before and after the three weeks.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 29 Nov 2017
- Start date
- 1 Feb 2018
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- University of Bath
- Diseases
- Type 2 diabetes
- NCT number
- NCT03362554
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Feb 2018 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-inflammatory medication: NSAIDs
Other illness
- Diagnosed diabetes
- Metabolic disorders
- Hypertension defined as \>160/100
- Cardiovascular disease
- Any bleeding disorder or taking anticoagulant medication
Other
- Inability to undertake exercise as determined by PAR-Q
- Ongoing or planned lifestyle changes (diet/exercise)
- Recent large shift in bodyweight (\>2.5%) within the last 3 months?
- Smoker (or having ceased \<6mo ago)
- Use of antibiotics within the last three months
- Use of pro/pre-biotics within one month of first trial day.
Who the study is looking for
- Male or female
- Age 40-65
- BMI ≥25 to ≤ 40 kg/m2
- Physical activity level \<1.75 (daily average)
- Waist size \>80 cm (female) or \>94 cm (male)
- Weight stable for \>3 months
Age in the registry: 40 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department for Health, University of Bath Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.