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Low-Carb diet fails to boost insulin sensitivity in type 1 diabetes study

NCT ID NCT04118374

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether eating fewer carbohydrates could help people with type 1 diabetes become more sensitive to insulin and improve blood vessel health. Fourteen adults on insulin pumps tried both a low-carb diet and a standard diet for one week each. The results showed no significant difference in insulin sensitivity between the two diets.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2024

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 60 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: * Age: 18-60 * HbA1c: 5.6-9.0% * Insulin delivery: must be on an insulin pump * Glucose Monitor: must use a continuous glucose monitor (CGM) * BMI 18-33 kg/m\^2 * Body Mass \>/= 50 kg ( 110 lbs) Exclusion Criteria: * severe hypoglycemia : \>/= 1 episode in the past 3 months * diabetes comorbidities (\>= 1 trip to emergency department for poor glucose control in the past 6 months, * New York Heart Association Class II-IV cardiac functional status * SBP \> 140 and DBP \> 100 mmHg, * eGFR by MDRD equation of \<60 mL/min/1.73m\^2 * AST or ALT \> 2.5 times the upper limit of normal * HCT \<35% medications * any antioxidant vitamin supplement (\<2 weeks before STUDY visit) * any systemic glucocorticoid * any antipsychotic * atenolol, metoprolol, propranolol * niacin * any thiazide diuretic * any OCP with \> 35 mcg ethinyl estradiol, * growth hormone * any immunosuppressant * any antihypertensive * any antihyperlipidemic other: * pregnancy * Tanner stage \< 5 * peri or postmenopausal woman * active smoker * gluten-free diet requirement Additional exclusion criteria for T1DM subjects * any diabetes medication except insulin

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Conditions

The condition(s) this trial relates to.

hyperinsulinism Insulin Resistance type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Diabetes mellitus, type 1

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.