Studying the effects of psychological and bodily factors on eating habits

Not Applicable

• Conditions: Obesity, patients with monogenic obesity, and patients undergoing upper GI surgery; Nutritional, Metabolic, Endocrine; Obesity, gastrectomy, monogenic obesity

• Registration Number: ISRCTN14809377
• Lead Sponsor: niversity of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-28
• Last Update Posted: 7 June 2021
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

All participants:
1. Aged 18-45 years
2. Written informed consent given
3. Estimated IQ =80 measured using the WASI-II Full Scale-2
4. Ambulatory
5. Normal or corrected-to-normal vision

Gastrectomy patient group:
1. Aged 18-60 years
2. If post-operative, clinically stable

Monogenic obesity patient group:
1. Identified mutation in MC4R, LepR, or SIM1 genes

Exclusion Criteria

All participants:
1. Not fluent English speaker
2. Current serious neurological or psychiatric illness, including neurodevelopmental disorders; schizophrenia spectrum and other psychotic disorders; bipolar and related disorders; substance-related and addictive disorders; obsessive-compulsive and related disorders; anorexia nervosa, bulimia nervosa, binge-eating disorder, or otherwise specified feeding or eating disorder; previous bariatric or gastric bypass (Roux-en-Y) surgery
3. Type 1 or Type 2 diabetes
4. Evidence of anaemia, metabolic or cardiovascular disease, or disease that may influence metabolism or blood measurements (such as cancer or thyroid disease)
5. Dietary restrictions that cannot be accommodated by the metabolic kitchen
6. Pregnancy or lactation
7. Contraindications to MRI scanning (such as pacemakers, metallic prostheses such as cochlear implants or heart valves, or shrapnel fragments)
8. Claustrophobic to a degree that they would feel uncomfortable in the MRI scanner

Lean group:
1. Left-handedness
2. BMI outside of the range 18.5-24.9 kg/m²
3. Lifetime history of any of the following DSM-5 psychiatric conditions:
3.1. Obsessive-Compulsive and Related Disorders
3.2. Trauma- and Stressor-Related Disorders
3.3. Dissociative Disorders
3.4. Somatic Symptom and Related Disorders
3.5. Disruptive, Impulse-Control, and Conduct Disorders
4. Recent history (previous 6 months) of any of the following DSM-5 psychiatric conditions
4.1. Depressive Disorders
4.2. Anxiety Disorders
5. Current use of antidepressant or anxiolytic medication

Diet-induced obesity group:
1. Left-handedness
2. BMI <29.9 kg/m²
3. Lifetime history of any of the following DSM-5 psychiatric conditions:
3.1. Obsessive-Compulsive and Related Disorders
3.2. Trauma- and Stressor-Related Disorders
3.3. Dissociative Disorders
3.4. Somatic Symptom and Related Disorders
3.5. Disruptive, Impulse-Control, and Conduct Disorders
4. Recent history (previous 6 months) of any of the following DSM-5 psychiatric conditions
4.1. Depressive Disorders
4.2. Anxiety Disorders
5. Current use of antidepressant or anxiolytic medication

Gastrectomy and monogenic obesity patient groups:
1. Treating clinician has any concerns that participation in the study may have a deleterious effect on the participant’s health or ongoing treatment

Study & Design

• Study Type: Observational
• Study Design: Not specified