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Can a Normal-Weight baseline improve heart risk assessment in type 1 diabetes?

NCT ID NCT06105931

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study aims to measure heart and metabolic risk markers—such as insulin resistance and fat distribution—in young adults aged 18 to 30 with type 1 diabetes and a body mass index under 25. Researchers will track changes over one year using glucose clamps and meal tests. The goal is to create a reference for how close obesity treatments can bring these markers to normal levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide a reference for how close GLP-1 obesity treatments bring cardiometabolic risk markers in people with type 1 diabetes to normal levels.
What could go wrong
This is a small, early-phase observational study with only 15 participants, so results may not apply broadly. It does not test any treatment directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 to ≤30 years * Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2. * HbA1c ≤10% * Clinical use of continuous glucose monitoring (CGM) * Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year: 1. Baseline creatinine \>1.0mg 2. Hypertriglyceridemia (\>400 mg/dl) 3. ALT ≥3.5 times the upper normal limit (UNL) Exclusion Criteria: * Current use of adjunctive diabetes medication or anti-obesity medication * Insulin dose \<0.5 units/kg/day * Use of lipid lowering prescription medication other than statins or omega-3 products * Doesn't meet MRI safety criteria or having claustrophobia * Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease * Known renal impairment * Pregnancy or lactation, or planning to become pregnant during the study period. * Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation. * Treatment with another investigational drug within the past 1 month * Past medical history of or self-reported corn allergy

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity TYPE1DIABETES

Contacts and locations

Locations

  • Yale Pediatric Diabetes Research

    New Haven, Connecticut, 06520, United States

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