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Metformin (Oral) for Intellectual Disability (METIDD Trial)

Phase 4

Recruiting

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65 years

Diagnosed with IDD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 4, 8, 12, 16, 10, 24

Awards & highlights

METIDD Trial Summary

This trial aims to study the effectiveness of a medication called metformin in helping overweight or obese adults with intellectual and developmental disabilities (IDD) who have gained weight due to taking antipsychotic medications

Who is the study for?

Adults aged 18-65 with intellectual and developmental disabilities (IDD) who are obese due to antipsychotic medications can join. They must have been on a stable dose of antipsychotics for at least 3 months, have a BMI ≥30 or ≥27 with weight-related health issues like high blood pressure. Participants should either abstain from sex or use reliable contraception during the trial.Check my eligibility

What is being tested?

The study is testing if Metformin helps reduce weight gain caused by antipsychotic drugs in adults with IDD. It's the first study of its kind and will compare Metformin's effects against a placebo while participants also receive lifestyle advice.See study design

What are the potential side effects?

Metformin may cause side effects such as stomach upset, diarrhea, nausea, and loss of appetite. Some people might experience changes in taste or mild rashes.

METIDD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with an intellectual developmental disorder.

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My BMI is over 30, or over 27 with a condition like high blood pressure or sleep apnea.

METIDD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 4, 8, 12, 16, 10, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 4, 8, 12, 16, 10, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 8, 12, 16, 10, 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Individual's percentage change in body weight

Secondary outcome measures

Between group (metformin vs placebo) absolute change in weight

Between group absolute change in BMI

Between group absolute change in waist circumference

+9 more

METIDD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Metformin (Oral)Experimental Treatment2 Interventions

50 participants will be administered oral metformin titrated to a maximum dose of 2000mg/day for 24 weeks.

Group II: PlaceboPlacebo Group2 Interventions

50 participants will be administered an identical oral placebo for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

Lifestyle Intervention

2001

Completed Phase 2

~8880

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,358 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being recruited for this research investigation?

"Affirmative. The details on clinicaltrials.gov confirm that this ongoing clinical trial is actively seeking individuals to participate. It was initially posted for recruitment on February 28, 2023, and has been recently updated as of January 11, 2024. To meet the research objectives, the study aims to enroll a total of 100 patients from a single site or location."

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, as per the data available on clinicaltrials.gov, this study is currently in the recruitment phase. The trial was initially posted on February 28th, 2023 and underwent its most recent revision on January 11th, 2024. For successful completion of this clinical trial, a total of 100 participants are sought from a single designated site."

Answered by AI

Is the clinical trial enrolling participants who are younger than 80 years old?

"This research study is currently seeking individuals who have surpassed the age of 18 and are below the age threshold of 65."

Answered by AI

Has the Food and Drug Administration granted official approval for Metformin in its oral form?

"Given that this trial is classified as a Phase 4 study, indicating that the treatment has already been approved, our team at Power rates the safety of oral metformin with a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

2023. "Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05744479.

All > Weight Gain