Metabolic disease Nutritional, Metabolic, Endocrine
Conditions
Interventions
Metabolic disease is defined as a range of diseases that increase the risk of type 2 diabetes, such as obesity, hypertension and cardiovascular disease. Worldwide, approximately 25% of the adult popul
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: In vivo study: 1. The participants on the waiting list for cholecystectomy 2. Male or female 3. Age between 18-75 years (inclusive) 4. Body mass index (BMI) of 18-35 kg/m2 5. Willingness and ability to give written informed consent and willingness and ability to understand, participate and comply with the study requirements In vitro study: 1. The participants on the surgery waiting list of the team with Dr Madhava Pai 2. Male or female 3. Age between 18-75 years (inclusive) 4. Body mass index (BMI) of 18-35 kg/m2 5. Willingness and ability to give written informed consent and willingness and ability to understand, participate and comply with the study requirements
Exclusion criteria
Exclusion criteria: In vivo study: 1. Abnormal ECG 2. Screening blood results outside of normal reference values 3. Weight change of =3 kg in the preceding 2 months 4. Current smokers 5. History of substance abuse and/or excess alcohol intake 6. Pregnancy 7. Formal medical diagnosis of Type 2 Diabetes, Cardiovascular disease, Cancer, Gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel), Kidney disease, Liver disease and Pancreatitis 8. Participation in a research study in the 12-week period prior to entering this study 9. Any blood donation within the 12-week period prior to entering this study 10. Use of antibiotics in the past 3 months 11. New medication in the past 3 months 12. Any other reason in the opinion of the investigator In vitro study 1. Screening blood results outside of normal reference values 2. Weight change of = 3kg in the preceding 2 months 3. History of substance abuse and/or excess alcohol intake 4. Pregnancy 5. Any other reason in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adipose tissue morphology measured using adipose tissue samples fixed for microscopic examination imaging and Haematoxylin and Eosin staining to determine adipocyte cell size, number and histological characteristics at the end of Week 12 after the tissue is collected 2. Insulin sensitivity and liver glucose metabolism measured using the Homeostatic model assessment (HOMA-IR). The blood insulin and glucose levels measured using the corresponding testing reagent kits at 0, 15, 30, 60, 90, 120, 180, 240, and 300 min during each assessment visit. In vitro Study: 1. Adipose tissue gene expression measured using Quantitative polymerase chain reaction (qPCR) after tissue is cultured for 24 h 2. After the preadipocyte is isolated from the tissue, the differentiation function will be measured via lipid accumulation on D14 (The last day of the differentiation period). | — |
Secondary
| Measure | Time frame |
|---|---|
| In vivo study: Circulating levels of glucose, insulin, free fatty acids, gut hormones and SCFA levels measured using the corresponding testing reagent kits. Venous blood samples will be collected at the fasting state during each review visit. In Vitro Study: Metabolite levels in adipose tissue and preadipocytes after treatment such as triglyceride and free fatty acid levels measured using the corresponding testing reagent kits after 24 h and on Day 14, respectively. | — |
Countries
England, United Kingdom
Contacts
Public ContactBaichen Lu
Outcome results
None listed