What side effects are associated with this type of intervention?

Common treatments for childhood obesity, such as Phentermine/Topiramate, often come with a range of side effects. For Phentermine/Topiramate specifically, the known side effects include paresthesia (tingling sensation), dizziness, dysgeusia (altered taste), insomnia, constipation, and dry mouth. These side effects are consistent with the pharmacological actions of Phentermine as a sympathomimetic amine anorectic and Topiramate as an anticonvulsant with weight loss properties. Other weight loss medications may have similar side effects, including gastrointestinal disturbances, sleep issues, and sensory changes.

What prior FDA approvals exist?

The FDA has approved Phentermine/Topiramate for the treatment of obesity in adults, and it is being studied for use in adolescents with type 2 diabetes and obesity. This combination includes Phentermine, a sympathomimetic amine anorectic, and Topiramate, an anticonvulsant with weight loss properties. While specific FDA approvals for childhood obesity treatments similar to Phentermine/Topiramate are not detailed in the provided context, this combination represents a promising approach due to its efficacy in weight loss and improvement in metabolic parameters.

What other types of research exist?

Promising novel alternatives to Phentermine/Topiramate for childhood obesity include GLP-1 receptor agonists like liraglutide and semaglutide, which have shown efficacy in weight reduction and improvement in metabolic parameters. Additionally, bupropion/naltrexone combination therapy is being explored for its potential benefits in weight management. These alternatives offer new avenues for treatment with a focus on both weight loss and metabolic health.

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Anti-obesity medication

Qsymia for Childhood Obesity

Q: What is the mechanism of action of this treatment?

Phentermine, a sympathomimetic amine anorectic, works by stimulating the release of norepinephrine, which suppresses appetite. Topiramate, an anticonvulsant, aids in weight loss by increasing energy expenditure and reducing appetite through multiple pathways. These mechanisms are important for childhood obesity patients as they help manage weight, improve metabolic health, and reduce the risk of obesity-related complications.

Phase < 1

Recruiting

Led By Megan Bensignor, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Obesity (BMI >/= the 95th percentile for age and sex)

Ages 12 to </= 20 years at study entry

Must not have

Any history of treatment with growth hormone

History of glaucoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial tests a weight-loss pill called Phentermine/Topiramate in teenagers with type 2 diabetes and obesity. The pill helps reduce appetite and cravings, which can lead to weight loss and better diabetes control. The study aims to determine if this pill is more effective than other treatments. Phentermine/Topiramate has been shown to help with weight loss and managing type 2 diabetes in previous studies.

Who is the study for?

This trial is for adolescents aged 12-20 with type 2 diabetes and obesity (BMI ≥95th percentile). Participants must have a diagnosis of T2D with HgbA1c ≥6.5%, no diabetes auto-antibodies, and not be pregnant or planning pregnancy. They should agree to use two forms of contraception if applicable, speak English or Spanish, and not have certain medical conditions like severe kidney impairment or history of seizures.

What is being tested?

The study tests Phentermine/Topiramate (Qsymia), an FDA-approved adult obesity medication, against a placebo in adolescents. The drug has shown significant weight loss in adults over one year. This trial will assess its effectiveness and safety profile in the younger population with both obesity and type 2 diabetes.

What are the potential side effects?

Common side effects observed include tingling sensations, dizziness, altered taste sensation, insomnia, constipation, and dry mouth. While it may improve blood pressure and cholesterol levels among other benefits, individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is in the top 5% for my age and sex.

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I am between 12 and 20 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with growth hormone in the past.

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I have a history of glaucoma.

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My kidney function is moderately or severely impaired.

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I have had gallstones in the past.

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I have a heart defect or a serious irregular heartbeat.

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I have a history of seizures.

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I am currently taking sulfonylurea medications.

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I have had weight loss surgery in the past.

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I have had kidney stones in the past.

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I have been diagnosed with an overactive thyroid.

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My thyroid disorder is untreated or my TSH levels are very low.

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My liver disease is moderate to severe.

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I have severe depression, diagnosed or with a PHQ-9 score of 15 or higher.

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I am currently taking medication that stimulates my body.

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I have been diagnosed with obesity caused by a single gene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in body mass index

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Open Label ExtensionExperimental Treatment1 Intervention

Participants in this phase of the study will receive open label phentermine/topiramate.

Group II: Placebo-Controlled PeriodPlacebo Group2 Interventions

Participants in this phase of the study will be randomized 1:1 to receive either phentermine/topiramate or placebo.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Phentermine, a sympathomimetic amine anorectic, works by stimulating the release of norepinephrine, which suppresses appetite. Topiramate, an anticonvulsant, aids in weight loss by increasing energy expenditure and reducing appetite through multiple pathways. These mechanisms are important for childhood obesity patients as they help manage weight, improve metabolic health, and reduce the risk of obesity-related complications.