ObesityPhase 4PLAQHVNCT04005768
Effect of Hydroxychloroquine Sulphate in Healthy Lean Females
A Phase 4 study testing Hydroxychloroquine Sulphate in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The effect of an acute administration of hydroxychloroquine sulphate will be investigated on hedonic food intake, appetite related sensations and gastrointestinal hormone release in healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Hydroxychloroquine Sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is female 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.
- Subject is allowed to take 2 Plaquenil capsuls for one visit with a maximal dose of 6.5 mg hydroxychloroquine sulphate per kg bodyweight.
- 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 non-childbearing 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.
Who cannot join
- Subject is under age of legal consent, male, 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 a QT-interval > 450 ms.
Show all 21Show fewer
- 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 has retinopathy.
- Subject suffers from psoriasis.
- Subject has porphyria.
- 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.
- 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.
- Subjects with lactose intolerance.
- Subjects with quinine allergy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Hydroxychloroquine Sulphate on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Healthy Female Subjects
The effect of an acute administration of hydroxychloroquine sulphate will be investigated on hedonic food intake, appetite related sensations and gastrointestinal hormone release in healthy female subjects.
Read the detailed description
Intragastric administration of a quinine-solution has shown to decrease hedonic food intake in healthy female volunteers. The effect of a tablet containing hydroxychloroquine sulphate on hedonic food intake in overweight female individuals has not been studied to date. The primary outcome of the current study is to evaluate the effect of hydroxychloroquine sulphate on hedonic food intake, assessed by ad libitum food intake of a chocolate milkshake one hour after dosing. The study is a randomized, placebo-controlled, double blinded cross-over study. Ten healthy lean females will be recruited as a proof of concept, before testing hydroxychloroquine sulphate in overweight female subjects. An acute dose of 400 mg hydroxychloroquine sulphate will be administered. Blood samples will be collected at regular time points to measure gastrointestinal hormone release and whole blood glucose levels. Appetite-related sensations will be scored at regular time points on visual analog scales.
- Conditions
- Obesity
- Being tested
- Hydroxychloroquine Sulphate, Placebo
- Keywords
- Bitter, Quinine, Motilin, Ghrelin, Food intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine SulphateDrug
Also called Plaquenil
After a stabilization period of 20 min and 10 min after the first blood collection, Plaquenil (Hydroxychloroquine sulfate) will be administered per os (total dose of 400 mg) in a randomized, double-blinded fashion.
PlaceboDrug
After a stabilization period of 20 min and 10 min after the first blood collection, Placebo will be administered per os (2 tablets) in a randomized, double-blinded fashion.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine Sulphate | Experimental | Plaquenil (hydroxychloroquine sulphate) will be acutely administered per os with 240 ml of water. Two tablets of 200 mg hydroxychloroquine sulphate each will be given. Receives: Drug: Hydroxychloroquine Sulphate |
| Placebo | Placebo comparator | Two placebo tablets will be acutely administered per os with 240 ml of water. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of hydroxychloroquine sulphate on hedonic food intake
Hedonic food intake will be assessed using a chocolate milkshake drinking task. Subjects are instructed to drink ad libitum from a chocolate milkshake until fully satiated. The milkshake will be weighted before and after the experiment. 1 g of chocolate milkshake = 1 kcal.
Measured: 60 min after plaquenil or placebo administration
Secondary outcomes (3)
The effect of hydroxychloroquine sulphate on gastrointestinal hormone release
Gastrointestinal hormone release will be measured in plasma samples collected at regular time points to assess the release of ghrelin and motilin.
Measured: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake.
The effect of hydroxychloroquine sulphate on glucose
Whole blood glucose levels will be measured at regular time points with a blood glucose meter.
Measured: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake.
The effect of hydroxychloroquine sulphate on appetite-related sensations
Hunger, prospective food consumption, satiety, fullness, bloating, belching, cramps and pain will be scored by the subjects on visual analog scales of 100 mm.
Measured: All appetite-related sensations will be scored every 10 min for a period of 110 minutes, starting 20 min before plaquenil or placebo administration and ending 90 min after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005768
- Sponsor's protocol ID
- S61870
- Acronym
- PLAQHV
- Status last verified
- Jul 2019
- First submitted
- 11 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydroxychloroquine Sulphate on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT04005768
- Acronym / sponsor ID
- PLAQHV / S61870
- Conditions
- Obesity
- Keywords
- Bitter, Quinine, Motilin, Ghrelin, Food intake
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of an acute administration of hydroxychloroquine sulphate will be investigated on hedonic food intake, appetite related sensations and gastrointestinal hormone release in healthy female subjects.
Detailed description
Intragastric administration of a quinine-solution has shown to decrease hedonic food intake in healthy female volunteers. The effect of a tablet containing hydroxychloroquine sulphate on hedonic food intake in overweight female individuals has not been studied to date. The primary outcome of the current study is to evaluate the effect of hydroxychloroquine sulphate on hedonic food intake, assessed by ad libitum food intake of a chocolate milkshake one hour after dosing. The study is a randomized, placebo-controlled, double blinded cross-over study. Ten healthy lean females will be recruited as a proof of concept, before testing hydroxychloroquine sulphate in overweight female subjects. An acute dose of 400 mg hydroxychloroquine sulphate will be administered. Blood samples will be collected at regular time points to measure gastrointestinal hormone release and whole blood glucose levels. Appetite-related sensations will be scored at regular time points on visual analog scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine Sulphate | Experimental | Drug: Hydroxychloroquine SulphatePlaquenil (hydroxychloroquine sulphate) will be acutely administered per os with 240 ml of water. Two tablets of 200 mg hydroxychloroquine sulphate each will be given. |
| Placebo | Placebo comparator | Drug: PlaceboTwo placebo tablets will be acutely administered per os with 240 ml of water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is female 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.
- Subject is allowed to take 2 Plaquenil capsuls for one visit with a maximal dose of 6.5 mg hydroxychloroquine sulphate per kg bodyweight.
- 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 non-childbearing 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.
Key exclusion criteria (21 listed)
- Subject is under age of legal consent, male, 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine SulphateAlso: PlaquenilAfter a stabilization period of 20 min and 10 min after the first blood collection, Plaquenil (Hydroxychloroquine sulfate) will be administered per os (total dose of 400 mg) in a randomized, double-blinded fashion. | Drug | Hydroxychloroquine Sulphate |
| PlaceboAfter a stabilization period of 20 min and 10 min after the first blood collection, Placebo will be administered per os (2 tablets) in a randomized, double-blinded fashion. | Drug | Placebo |
Primary outcome
The effect of hydroxychloroquine sulphate on hedonic food intake
Time frame: 60 min after plaquenil or placebo administration
Hedonic food intake will be assessed using a chocolate milkshake drinking task. Subjects are instructed to drink ad libitum from a chocolate milkshake until fully satiated. The milkshake will be weighted before and after the experiment. 1 g of chocolate milkshake = 1 kcal.
3 secondary outcomes
The effect of hydroxychloroquine sulphate on gastrointestinal hormone release
Time frame: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake.
The effect of hydroxychloroquine sulphate on glucose
Time frame: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake.
The effect of hydroxychloroquine sulphate on appetite-related sensations
Time frame: All appetite-related sensations will be scored every 10 min for a period of 110 minutes, starting 20 min before plaquenil or placebo administration and ending 90 min after administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquine Sulphate in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wout Verbeure (16373765 ext. +32, wout.verbeure@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of hydroxychloroquine sulphate on hedonic food intake (time frame: 60 min after plaquenil or placebo administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.