Reproductive hormone effects Nutritional, Metabolic, Endocrine Reproductive hormone effects
Conditions
Interventions
Part A: Intravenous infusion of vehicle during one study visit and intravenous infusion of a gut hormone (i.e. glucagon, glucagon-like peptide-1, oxyntomodulin, peptide-YY or substance P) during a sep
glucagon infusion and vehicle infusion visits
oxyntomodulin infusion and vehicle infusion visits
and substance P infusion a
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 – 60 years 2. Male or female 3. Stable body weight for the preceding 3 months 4. 12-lead ECG with no clinically significant abnormalities as judged by the investigators 5. Full blood count, urea and electrolytes, thyroid function tests, liver function tests and glucose within 2 x the upper limit of normal 6. Conditions that predispose subfertility: BMI >25, Pre-diabetes, Type 2 diabetes
Exclusion criteria
Exclusion criteria: 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer 2. Pregnancy or breastfeeding 3. History of hypersensitivity to any of the components of the infusions 4. Treatment with an investigational drug within the preceding 2 months 5. Volunteers who have or intend to donate blood or blood products within three months before or following study completion 6. A history of alcoholism or substance abuse within the preceding 5 years 7. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease 8. A history of cancer 9. Volunteers with a medical or psychological condition that would impair their ability to participate reliably in the study or give informed consent 10. Smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: 1. Luteinising hormone (LH) pulsatility, LH levels, follicle-stimulating hormone levels and testosterone levels in males measured using blood tests during the vehicle and hormone infusions 2. Oestrogen and progesterone levels in females measured blood tests during the vehicle and hormone infusions Part B: 1. OGTT/IVGTT/MMTT insulin and glucose levels measured using blood tests during vehicle and hormone infusions 2. OGTT/IVGTT/MMTT insulin secretion measured using blood tests during vehicle and hormone infusions 3. OGTT/IVGTT/MMTT insulin sensitivity and disposition indices measured using blood tests during vehicle and hormone infusions 4. MMTT food intake measured using scales during vehicle and hormone infusions 5. MMTT Energy expenditure measured using calorimetry and infrared thermography during vehicle and hormone infusions | — |
Secondary
| Measure | Time frame |
|---|---|
| Part B: Pre- and post-meal nausea, hunger and fullness ratings measured using visual analogue scales during hormone and vehicle infusions. | — |
Countries
England, United Kingdom
Contacts
Public ContactChioma Izzi-Engbeyaa
Outcome results
None listed