The Effect of Liraglutide on the GIT

NCT04008290 | Unknown Phase 4

• 1 other identifier: S61865
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Liraglutide is a glucose-like peptide 1 agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. We want to investigate whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole blood levels, hunger ratings and ad libitum food intake in healthy volunteers.

Conditions

Obesity

Keywords

Liraglutide; MMC; Motilin; Ghrelin; Hunger; glucose; ad libitum food intake

Outcome Measures

Primary Outcomes (1)

• MMC activity compared between placebo and treatment with liraglutide

  On the 4th day of a treatment arm, the liraglutide or placebo injection is combined with a motility study. A solid-state, high-resolution manometry catheter is placed to measure intragastric pressure (IGP; mmHg). Antroduodenal contractility will be measured during the fasted state.

  The catheter will be placed 1 hour before the subcutaneous administration. Antroduodenal contractility will be measured for 5 hours after liraglutide or placebo injection.

Secondary Outcomes (4)

• Gastrointestinal hormone release compared between placebo and treatment with liraglutide

  Reference sample is taken at 7:50 in the morning. Other blood samples are taken from every 30 min after the injection (8am). The 4th day, this stops at 13:00 and the 5th day at 15:00. No samples are taken during the buffet at day 5 (13:30 until 14:15).

• Hunger sensations compared between placebo and treatment with liraglutide

  Hunger is scored every 5 min for 6 hours at day 4 of the treatment, starting at 7:00 and ending at 13:00. At day 5, hunger is scored every 5 min for 7 hours and 20 min starting at 7:40 and ending at 15:00, except during 13:30 and 14:15 (buffet).

• Ad libitum food intake compared between placebo and treatment with liraglutide

  The buffet will be given 5 hours after the consumption of a standardized breakfast which was given half an hour after the subcutaneous injection. Subjects have 45 min to finish the buffet.

• Glucose whole blood levels compared between placebo and treatment with liraglutide

  Reference sample is taken at 7:50 in the morning. Other glucose samples are taken from every 30 min after the injection (8am). The 4th day, this stops at 13:00 and the 5th day at 15:00. No samples are taken during the buffet at day 5 (13:30 until 14:15).

Study Arms (2)

0.6 mg Liraglutide

EXPERIMENTAL

For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl containing 0.6 mg liraglutide.

Drug: 0.6 mg Liraglutide

Placebo

PLACEBO COMPARATOR

For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl saline (0.9%) solution.

Drug: Placebo

Interventions

0.6 mg Liraglutide DRUG

For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 0.6 mg liraglutide. The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.

Also known as: Victoza

0.6 mg Liraglutide

Placebo DRUG

For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of placebo (0.9% saline solution). The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.

Also known as: saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is female or male between 18 and 65 years of age.
• Subject has a BMI between 18 and 25 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
• Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of nonchildbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

You may not qualify if:

• Subject is under age of legal consent, pregnant or breastfeeding.
• Subject with a BMI ≤ 18 kg/m² or BMI ≥ 25 kg/m².
• Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
• Subject has diabetes.
• Subject has a significant heart, lung, liver or kidney disease.
• Subject has any history of a neurological disorder.
• Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
• Subject shows abnormal eating behavior or has an eating disorder.
• History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
• History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
• Subject consumes excessive amounts of alcohol, defined as \>14 units per week for women and \>21 units per week for men.
• Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
• High caffeine intake (\> 500 ml coffee daily or equivalent).
• Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
• Recent participation (\<30 days) or simultaneous participation in another clinical study.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jan Tack

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wout Verbeure

CONTACT

16373765; wout.verbeure@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 5, 2019
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 5, 2019

Record last verified: 2019-07