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AzTrials

Type 1 DiabetesPhase 1MANATEE-T1DNCT05065372

MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes

A Phase 1 study testing Metformin Hcl 1000Mg Tab, Aminohippurate Sodium 20 % Injection and Iohexol 300 Mg/mL Injectable Solution in people with Type 1 Diabetes and Diabetic Kidney Disease, run by Kalie Tommerdahl at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Read more about this study

Who is it for?
Ages 12 to 25 years
What is being tested?
Metformin Hcl 1000Mg Tab, Aminohippurate Sodium 20 % Injection and Iohexol 300 Mg/mL Injectable Solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesUnited States
Study dates
1 Jul 2022to 31 Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 12 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • T1D and using an automated insulin delivery system or multiple daily insulin injections/manual insulin pump plus continuous glucose monitor for > 6 months
  • Age 12-25 years
  • Use of an automated insulin delivery system or multiple daily insulin injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor for > 6 months
  • Hemoglobin A1c < 11%
  • No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) (within 30 days)
  • Pubertal (Tanner stage ≥ 2)
  • Weight > 54 kg and BMI > 5th percentile for age and sex

Who cannot join

  • Blood pressure > 140/90 mm Hg
  • Hemoglobin < 9 g/dL
  • Estimated glomerular filtration rate < 60 mL/min/1.73 m2 or serum creatinine > 1.2 mg/dL or history of urinary albumin to creatinine ratio ≥ 300mg/g or history of acute kidney injury
  • Use of anti-diabetic agents except insulin, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB's), diuretics, daily non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, sulfonamides, procaine, thiazosulfone or probenecid
  • Seafood or iodine allergy
  • Pregnancy or breast feeding for females

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kalie Tommerdahl, MD contact

(206) 616-9015

ktomme@uw.edu

United States2 sites, 1 recruiting

  • Children's Hospital Colorado/University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Active, not recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98102

    Kalie Tommerdahl, MD, (206) 616-9015, ktomme@uw.edu

    Kalie Tommerdahl, MD

    Recruiting

Other trials in United States

About this study

Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Yet, type 1 diabetes is a complex disease with pathophysiology that extends beyond beta-cell injury and insulin deficiency to include insulin resistance and renal vascular resistance, factors that accelerate cardiovascular disease risk. We have shown that metformin improved peripheral insulin sensitivity and vascular stiffness in youth with type 1 diabetes on multiple daily insulin injections or standard insulin pumps. However, metformin's effect on kidney and endothelial outcomes, and the effects of type 1 diabetes technologies, with or without metformin, on any cardiovascular or kidney outcome, remains unknown. Automated insulin delivery systems combine an insulin pump, continuous glucose monitor, and control algorithm to modulate background insulin delivery and decrease peripheral insulin exposure while improving time in target range and reducing hypoglycemia. We hypothesize that automated insulin delivery systems, particularly when combined with metformin, may modulate renal vascular resistance and insulin sensitivity, thereby impacting cardiometabolic function. MANATEE-T1D is a randomized, double-blind, placebo-controlled trial of 4 months of metformin 2,000 mg daily in 40 youth aged 12-25 years with type 1 diabetes on automated insulin delivery systems vs. 20 control youth with type 1 diabetes on multiple daily injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor which will assess for changes in calculated renal vascular resistance and gold standard measures of whole-body and adipose insulin sensitivity, arterial stiffness, and endothelial function.

Being tested
Metformin Hcl 1000Mg Tab, Aminohippurate Sodium 20 % Injection, Iohexol 300 Mg/mL Injectable Solution, Placebo
Keywords
Type 1 diabetes, Youth, Insulin sensitivity, Cardiovascular function, Diabetic kidney disease
Medical subject headings
Diabetes Mellitus, Type 1, Diabetic Nephropathies, Cardiovascular Diseases, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin Hcl 1000Mg TabDrug

    Also called Fortamet, Glucophage, Glumetza, Riomet

    Agent used to modify insulin sensitivity

  • Aminohippurate Sodium 20 % InjectionDrug

    Also called Sodium 4-amino hippurate (PAH) injection 20% (2g/10 mL), Para-aminohippurate, Aminohippuric acid

    Diagnostic aid/agent used to measure renal plasma flow and calculate renal vascular resistance

  • Iohexol 300 Mg/mL Injectable SolutionDrug

    Also called Omnipaque 300

    Diagnostic aid/agent used to measure glomerular filtration rate

  • PlaceboDrug

    Identical to Metformin Hcl 1000Mg Tab but without metabolic effects

Study groups in NCT05065372
Study groupRoleWhat they receive
Metformin plus automated insulin delivery systemActive comparatorSome participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with metformin and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in addition to assessments of cardiovascular and endothelial function.
Receives: Drug: Metformin Hcl 1000Mg Tab; Drug: Aminohippurate Sodium 20 % Injection; Drug: Iohexol 300 Mg/mL Injectable Solution
Placebo plus automated insulin delivery systemPlacebo comparatorSome participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with a placebo pill which is identical in appearance to the metformin pill and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in addition to assessments of cardiovascular and endothelial function.
Receives: Drug: Aminohippurate Sodium 20 % Injection; Drug: Iohexol 300 Mg/mL Injectable Solution; Drug: Placebo
Multiple daily insulin injections or manual insulin pump plus continuous glucose monitorOtherParticipants with type 1 diabetes using multiple daily injections or an insulin pump in manual mode plus a continuous glucose monitor will not be randomized to receive medication treatment but will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in addition to assessments of cardiovascular and endothelial function.
Receives: Drug: Aminohippurate Sodium 20 % Injection; Drug: Iohexol 300 Mg/mL Injectable Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal vascular resistance

    Renal plasma flow will be measured by para-aminohippurate clearance and used to calculate renal vascular resistance

    Measured: 4 months

  2. Glomerular filtration rate

    Measured by iohexol clearance

    Measured: 4 months

Secondary outcomes (2)

  1. Arterial stiffness

    Measured by SphygmoCor

    Measured: 4 months

  2. Insulin sensitivity

    Measured by hyperinsulinemic-euglycemic clamp

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start1 Jul 2022
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065372
Sponsor's protocol ID
21-3483
Other IDs
K23HL159292
Acronym
MANATEE-T1D
Status last verified
Jun 2025
First submitted
13 Sep 2021
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metformin Hcl 1000Mg Tab, Aminohippurate Sodium 20 % Injection and Iohexol 300 Mg/mL Injectable Solution in people with Type 1 Diabetes and Diabetic Kidney Disease, run by Kalie Tommerdahl at 2 sites in United States.

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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kalie Tommerdahl, MD ((206) 616-9015, ktomme@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal vascular resistance (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065372.

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 13 Jun 2025.

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