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Type 1 DiabetesNCT05985135

Impact of Insulin Deprivation and Hyperglycemia on Plasma Protein Synthesis in People With Type 1 Diabetes Mellitus

A study testing Muscle Biopsy, Jell-O with Amino acids and Dextrose in people with Type 1 Diabetes, run by Mayo Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research is being done to better understand how insulin effects muscle, blood, and the body in people with Type 1 Diabetes. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
Muscle Biopsy, Jell-O with Amino acids and Dextrose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2026to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Able to provide written consent.
  • Able to provide written consent.
  • T1DM treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) (not Degludec).

Who cannot join

  • BMI < 20 or > 32 kg/m^2.
  • Celiac disease.
  • Pregnancy.
  • Smoking.
  • Reported history of illicit substance use.
  • History of active cardiovascular, cerebrovascular, or peripheral vascular disease.
Show all 30Show fewer
  • Active renal disease evidenced by estimated glomerular filtration rate (GFR) < 50 mL/min/1.73 m^2.
  • Severe peripheral or autonomic neuropathy.
  • Dementia or any other neurologic disease.
  • Uncontrolled psychiatric disease.
  • Any learning disability.
  • Anemia.
  • Thyroid-stimulating hormone (TSH) ≥ 7 or TSH ≤ 7 and free T4 ≤ 0.9.
  • Hemoglobin A1c > 9.0%.
  • Type 2 Diabetes Mellitus (T2DM), or impaired fasting glucose.
  • Detectable C peptide.
  • BMI < 20 or > 32 kg/m^2.
  • Celiac disease.
  • Pregnancy.
  • Smoking.
  • Reported history of illicit substance use.
  • History of active cardiovascular, cerebrovascular, or peripheral vascular disease.
  • Active renal disease evidenced by estimated GFR < 50 mL/min/1.73 m^2.
  • Severe peripheral or autonomic neuropathy.
  • Dementia or any other neurologic disease.
  • Uncontrolled psychiatric disease.
  • Any learning disability.
  • Anemia.
  • TSH ≥ 7 or TSH ≤ 7 and free T4 ≤ 0.9.
  • T2DM, or impaired fasting glucose.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Impact of Insulin Deprivation and Hyperglycemia on Plasma Protein Synthesis in People With Type 1 Diabetes Mellitus and Diabetes After Total Pancreatectomy

This research is being done to better understand how insulin effects muscle, blood, and the body in people with Type 1 Diabetes.

Read the detailed description

Insulin's contribution in controlling glucose homeostasis has been well appreciated but, its role in maintaining proteome homeostasis is less understood. Some animal and human studies have demonstrated that insulin signaling regulates protein synthesis and degradation as well as posttranslational modifications at the tissue level. Insulin's effect on the muscle's mitochondrial proteo-stasis has also been elucidated. Insulin deprivation increases global synthesis of splanchnic proteins based on isotope dilution studies across splanchnic bed. Most plasma proteins are derived from liver and preliminary studies suggest that synthesis rates of some plasma proteins increase while others decrease. Fractional rates of synthesis of various plasma proteins from the liver have been demonstrated in insulin deprivation state. These proteins might be implicated in the development of some of the complications from diabetes mellitus type 1. (T1DM) especially of macrovascular. Researchers have recently developed an isotope-based methodology to simultaneously measure in vivo synthesis rates of multiple plasma proteins in human.

In order to further investigate the effects of insulin deprivation researchers will apply the novel non-radioactive stable isotope-based approach on the rate of different plasma protein synthesis in T1DM and Diabetes after total pancreatectomy (DATP) in comparison with non-diabetic controls. Researchers will study pancreatectomized people because like T1DM they also are insulin deficient but unlike pancreatectomized people also are deficient in glucagon. Some tantalizing data from many studies indicate that glucagon also have catabolic effect not only on liver derived proteins but also on skeletal muscle-based proteins. Since skeletal muscle has no glucagon receptors, researchers hypothesize that unknown factors are released to the circulation that act on skeletal muscle to release amino acids for consumption in liver. Researchers will measure amino metabolites, acyl carnitines, organic acids, and ceramides in plasma and determine the blood exosome cargo by mass spectrometry-proteins and lipids and miRNA by PCR.

Researchers have previously shown reduced muscle mitochondrial ATP production during insulin deprivation in both T1D humans and diabetic mice and here researchers will measure mitochondrial energy dynamics in all study participants by the established techniques available in our lab.

Conditions
Type 1 Diabetes
Being tested
Muscle Biopsy, Jell-O with Amino acids, Dextrose
Keywords
Continuous subcutaneous insulin infusion, Multiple daily injections of insulin
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Muscle BiopsyProcedure or surgery

    Needle muscle biopsy of the outer thigh muscle

  • Jell-O with Amino acidsOther

    An amino acid mixture containing 13C6 Lysine isotope label

  • DextroseDietary supplement

    Intravenous form of sugar

Study groups in NCT05985135
Study groupRoleWhat they receive
Type 1 Diabetes Mellitus (T1DM) Insulin DeprivedExperimentalSubjects will have their insulin infusions replaced with saline and have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
Receives: Procedure: Muscle Biopsy; Other: Jell-O with Amino acids
Type 1 Diabetes Mellitus (T1DM) Insulin TreatedExperimentalSubjects will continue their baseline insulin infusion while maintaining a target blood glucose range. Blood draws will be obtained to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
Receives: Procedure: Muscle Biopsy; Other: Jell-O with Amino acids
Type 1 Diabetes Mellitus (T1DM) Insulin-Treated with HyperglycemiaExperimentalSubjects will be continue their baseline insulin infusion for 2 hours and then receive an intravenous dextrose infusion to maintain elevated blood sugar levels. Blood draws will be obtained to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
Receives: Procedure: Muscle Biopsy; Other: Jell-O with Amino acids; Dietary Supplement: Dextrose
Non-Diabetic ControlsOtherSubjects will have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
Receives: Procedure: Muscle Biopsy; Other: Jell-O with Amino acids
Diabetes after Total Pancreatectomized (DATP) Insulin TreatedExperimentalSubjects will continue their baseline insulin infusion while maintaining a target blood glucose range. Blood draws will be obtained to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
Receives: Procedure: Muscle Biopsy; Other: Jell-O with Amino acids
Diabetes after Total Pancreatectomized (DATP) Insulin DeprivedExperimentalSubjects will have their insulin infusions replaced with saline and have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
Receives: Procedure: Muscle Biopsy; Other: Jell-O with Amino acids

What is being measured

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

  1. Protein synthesis

    Measurement of isotope abundance in peptides derived from the digested proteins

    Measured: Approximately 7 hours

Timeline

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

  1. First posted14 Aug 2023
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Why it stopped: Changed IRB number

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985135
Sponsor's protocol ID
21-000001
Status last verified
Jul 2026
First submitted
2 Aug 2023
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Muscle Biopsy, Jell-O with Amino acids and Dextrose in people with Type 1 Diabetes, run by Mayo Clinic at 1 site 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 3 inclusion and 30 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: withdrawn, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protein synthesis (time frame: Approximately 7 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Aug 2026.

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