Coronary heart disease - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

NHS Greater Glasgow and Clyde (UK)

Recruitment countries:

United Kingdom

Health condition studied:

Obesity
Nutritional, Metabolic, Endocrine
Obesity

URL:

Link to the clinical trial website

About the trial

Interventions:

Bariatric surgery (surgical procedures developed for the primary purpose of weight loss currently laparoscopic gastric banding, sleeve gastrectomy and roux-en-y gastric bypass)

2000 patients undergoing bariatric surgery in the NHS and private sector in Scotland, UK, over a 5 year period will be recruited. The participants will be followed up for a mean of 10 years. The mortality, weight, incident type 2 diabetes mellitus (T2DM), coronary heart disease (CHD), cardiovascular disease (CVD), cancer, fractures, nutritional blood markers, anxiety, depression, post-operative complications, revisional surgery rates, health related quality of life, glycaemic control, diabetic complications and diabetes medications will be recorded.

Key inclusion and exclusion criteria:

• Inclusion criteria: Undergoing bariatric surgery in NHS secondary care and private practice in Scotland, UK
• Exclusion criteria: Does not meet inclusion criteria

• Age minimum:
• Age maximum:
• Gender: Both

Primary outcomes:

10 year mortality

Secondary outcomes:

In the 10 years following bariatric surgery:
1. Change in weight / body mass index (BMI) from pre-bariatric surgery weight
2. Rate of incident type 2 diabetes
3. Incidence of fatal and non-fatal coronary heart disease, cardiovascular disease, cancer and fractures
4. Incidence of incidence of nutritional deficiencies
5. Change in incidence of depression and anxiety compared to baseline level pre-operatively
6. Incidence of complications immediately post-operatively and the need for readmission for revisional procedures
7. Change in health-related quality of life compared to baseline level pre-operatively
8. Change in glycaemic control, cardiovascular risk factors, chronic kidney disease (CKD), retinopathy and medications prescribed in patients with diabetes compared to equally obese patient with diabetes who did not have bariatric surgery
9. Cost of the procedure and follow-up (to inform cost-effectiveness analysis)

Target sample size:

2000

Study type:

Observational

Study design:

Multi-centre prospective cohort study (Quality of life)

Contacts:

• Name:
• Address:
• Phone:
• Email:
• Affiliation:

• Name: Jennifer Logue
• Address: BHF Cardiovascular Research Centre University of Glasgow 126 University Place
• Phone:
• Email:
• Affiliation:

Technical details

Scientific title:

SurgiCal Obesity Treatment Study: a prospective cohort study

Sources of monetary support:

NIHR Health Technology Assessment Programme - HTA (UK) (10/42/02)

Secondary sponsors:

Main ID:

ISRCTN47072588

Secondary ID:

HTA: 10/42/02

Register:

ISRCTN

Date of registration:

30/09/2024

Date of first enrollment:

01/01/2025

Last refreshed:

13 January 2025