Effect of Intranasal Insulin on Cognitive Processes and Appetite

NCT03632681 | Completed

• 1 other identifier: RG_17-102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of intranasal insulin on cognitive processes (behavioural and neural) in healthy lean and obese female adults. All subjects will receive a single-dose of intranasal insulin and/or placebo (on different days) before participating in several cognitive tasks.

Conditions

Obesity

Keywords

Cognitive processes; Reward processes; fMRI; Insulin

Outcome Measures

Primary Outcomes (1)

• fMRI brain response during inhibition to a food stimuli

  Neural activation during correct inhibition food vs. non-food stimuli trail. Comparing the brain response when subjects correctly withhold for food vs a sports item.

  14 minutes

Secondary Outcomes (11)

• Delay discount of food reward

  5 minutes

• Delay discount of money reward

  5 minutes

• fMRI brain activity in food picture task

  18 minutes

• Recall pictures

  5 minutes

• Recall words

  10 minutes

Study Arms (2)

Insulin

ACTIVE COMPARATOR

In this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated

Drug: Intranasal Insulin

Placebo

PLACEBO COMPARATOR

In this arm a single-dose intranasal placebo will be administrated

Drug: Intranasal Placebo

Interventions

Intranasal Insulin DRUG

Intranasal insulin

Also known as: Insulin, Actrapid

Insulin

Intranasal Placebo DRUG

Intranasal placebo manufactured to mimic smell of insulin

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects
• Age 18-65 years at start of the study
• Body Mass Index (BMI) between 18 and 25 kg/m2 for the lean group and between 30 and 40 kg/m2 for the obese group
• Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
• Ability to give informed consent
• Fluent English speaking
• Willingness to be informed about chance findings of pathology

You may not qualify if:

• Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
• Tattoos, that are older than 15 years
• Claustrophobia
• Limited temperature perception and/or increased sensitivity to warming of the body
• Pathological hearing ability or an increased sensitivity to loud noises
• Lack of ability to give informed consent
• Operation less than three months ago
• Simultaneous participation in other studies that involve drugs intake or blood spending
• Acute illness or infection during the last 4 weeks
• Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome)
• Moderate or severe head injury
• Eating disorders
• No metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression) or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
• Intake of any medication that can interfere with the drug or measurements.
• Current weight loss regimens, or more then 5kg weight loss in the last 3 months

Sponsors & Collaborators

• University of Birmingham: lead
• Queen Elizabeth Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Univerisity of Birmingham

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maartje SPetter, PhD

  Univerisity of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: April 23, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 2, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The study protocol will be shared before including the first participant. The data will become available after the last participant has finished the study.
• Access Criteria: All researchers

Locations

GB (1)