Metabolic Testing for Type 1 Diabetes

(LTD Trial)

Recruiting at 1 trial location

Overseen By Mittendorfer Lab

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must be taking: Insulin

Must not be taking: Lipid metabolism drugs

Disqualifiers: Hypothyroidism, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how type 1 diabetes (T1D) might increase the risk of heart problems, such as heart attacks and strokes. Researchers will compare how the body processes certain proteins and fats in people with T1D to those without. Metabolic testing, including a Comprehensive Metabolic Panel or Resting Metabolic Rate test, will gather this information. Ideal participants are adults with T1D on stable insulin treatment or healthy individuals not taking medications that affect fat processing. As an unphased trial, participants contribute to foundational research that may improve understanding and management of T1D-related heart risks.

Will I have to stop taking my current medications?

The trial requires that participants with type 1 diabetes only use insulin and no other diabetes medications. Additionally, you cannot use medications or supplements that affect lipid metabolism (how your body processes fats).

What prior data suggests that metabolic testing is safe for participants?

Research has shown that metabolic testing is generally safe. A comprehensive metabolic panel, a common blood test, checks various substances in the body, such as proteins and enzymes. This test is widely used, and most individuals tolerate it well. No reports of serious side effects from this testing method exist, making it a routine and safe procedure.

In studies involving individuals with type 1 diabetes and healthy participants, metabolic profiling has been conducted without major safety issues. This indicates that the testing poses a low risk for participants. Overall, metabolic testing is a standard procedure and typically does not cause serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about metabolic testing for Type 1 Diabetes because it offers a new approach to understanding and managing the condition. Unlike traditional treatments that focus on insulin delivery or blood sugar monitoring, metabolic testing aims to provide a deeper insight into how the body processes energy and nutrients. This could lead to more personalized and effective management strategies for individuals with Type 1 Diabetes, potentially improving their quality of life and long-term health outcomes. By identifying unique metabolic patterns, this method might uncover new ways to tailor treatments to each person's specific needs.

What evidence suggests that metabolic testing is effective for understanding cardiovascular risk in type 1 diabetes?

Research shows that metabolic testing can reveal how the body processes substances like proteins and minerals. In this trial, participants will be divided into a control group and a T1D group to assess these differences. A comprehensive metabolic panel (CMP) checks these substances in the blood, revealing potential risks or problems in people with type 1 diabetes (T1D). Studies have found that the metabolome, which includes all the small molecules in the body, can distinguish people with different fitness levels, suggesting its usefulness for diagnosis. Although metabolic testing is not a treatment, it monitors changes in blood markers to show how T1D might lead to heart disease. This information is crucial for creating personalized care plans for people with T1D. ^{4 6 7 8 9}

Who Is on the Research Team?

Bettina Mittendorfer

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This study is for adults aged 18-45 with Type 1 Diabetes who haven't had severe hypoglycemia recently, are on a stable insulin regimen without other diabetes meds, aren't obese, and have certain levels of blood fats and sugars. Healthy controls must meet similar criteria but also have normal HbA1c levels.

Inclusion Criteria

Your blood sugar level when you haven't eaten should be less than 100 milligrams per deciliter.

Your HbA1c level is less than 6.5% when you haven't eaten for a long time.

Additional inclusion criteria for control subjects:

Exclusion Criteria

You do more than 1.5 hours of planned exercise every week.

I have a condition like hypothyroidism that affects my cholesterol levels.

Conditions that would make it impossible to complete the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including apolipoprotein and triglyceride kinetics using intravenous stable isotope labeled infusions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metabolic testing

Trial Overview The trial aims to understand how Type 1 Diabetes affects the risk of heart disease by comparing fat and protein particles in the blood (apolipoproteins and triglycerides) between those with T1D and healthy individuals through metabolic testing.

How Is the Trial Designed?

Group I: Control group Experimental Treatment 1 Intervention

Healthy control group

Group II: T1D group Active Control 1 Intervention

T1D group

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

This study analyzed urine samples from patients with different types of diabetes, including 14 with HNF1A-MODY, 17 with GCK-MODY, 14 with type 2 diabetes, and 34 normoglycaemic controls, using advanced metabolic profiling techniques.

While certain metabolites like betaine, valine, glycine, and glucose were found to be elevated in HNF1A-MODY patients, the study concluded that there are no strong urinary biomarkers to reliably distinguish monogenic diabetes subtypes from type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic profiling in Maturity-onset diabetes of the young (MODY) and young onset type 2 diabetes fails to detect robust urinary biomarkers. Gloyn, AL., Faber, JH., Malmodin, D., et al.[2022]

Fasting hyperglycemia (≥ 7 mmol/l) is a key diagnostic indicator of diabetes mellitus, which affects multiple metabolic processes including carbohydrate, lipid, and protein metabolism.

Dynamic tests like oral and intravenous glucose tolerance tests, along with HbA1c measurements (targeting < 7%), are essential for accurately assessing metabolic control and beta-cell function in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic tests in the clinical management of diabetes. Picardi, A., Pozzilli, P.[2022]

Metabolomics, using techniques like mass spectrometry, has shown promise in identifying biomarkers for insulin resistance and type 2 diabetes, particularly focusing on amino acids and lipid metabolism.

Branched-chain amino acids may serve as effective screening biomarkers for early diabetes risk, potentially allowing for timely dietary and exercise interventions to prevent the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards metabolic biomarkers of insulin resistance and type 2 diabetes: progress from the metabolome. Roberts, LD., Koulman, A., Griffin, JL.[2022]

Effective diabetes management requires tailored assessment criteria based on the severity of the disease, with plasma and urine glucose measurements remaining the standard for evaluating control.

In mild Type II diabetes, achieving normal glucose levels post-meal is possible, but in severe Type I diabetes, maintaining normoglycemia is typically only feasible before meals, highlighting the risk of hypoglycemia with aggressive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods of assessing diabetic control. Molnar, GD., Marien, GJ., Hunter, AN., et al.[2019]

The urine c-peptide creatinine ratio (UCPCR) is a promising diagnostic tool for distinguishing between type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), showing high sensitivity (84.4%) and specificity (91.6%) for T1DM and even higher sensitivity (92.8%) for T2DM when using specific cut-off values.

For monogenic diabetes (MODY), UCPCR demonstrated excellent specificity (98.0%) and good sensitivity (85.2%), indicating its potential effectiveness in clinical settings, although further large-scale studies are needed to confirm its routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Test Accuracy of Urine C-peptide Creatinine Ratio for the Correct Identification of the Type of Diabetes: A Systematic Review. Pappachan, JM., Sunil, B., Fernandez, CJ., et al.[2022]

A study involving 79 subjects identified three key metabolic markers—5-oxoproline, glutamate, and homocysteine—that are significantly altered in patients with fulminant type 1 diabetes (FT1DM) compared to healthy controls and other diabetes types.

These metabolic signatures could help in the rapid and accurate diagnosis of FT1DM, which is crucial for timely treatment to prevent severe clinical consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum metabolic signatures of fulminant type 1 diabetes. Lu, J., Zhou, J., Bao, Y., et al.[2015]

Diabetes is a complex group of diseases with different causes and responses to treatment, making accurate diagnosis crucial, especially for rare forms like monogenic diabetes.

Many patients with monogenic diabetes, such as MODY or neonatal diabetes, miss out on potential benefits from genetic testing due to high costs and complexity; developing efficient and affordable screening tests using biomarkers could improve diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical application of non-genetic biomarkers for differential diagnosis of monogenic diabetes. Owen, KR., Skupien, J., Malecki, MT.[2023]

Using intermittent continuous glucose monitoring (CGM) alongside traditional A1C testing can enhance diabetes management by providing clearer insights into glucose patterns and their relationship to A1C levels.

The integration of the ambulatory glucose profile (AGP) with novel flash continuous glucose monitoring (FCGM) technologies may improve patient care by making glucose data more accessible and interpretable, although more research is needed to establish best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PROFESSIONAL FLASH CONTINUOUS GLUCOSE MONITORING WITH AMBULATORY GLUCOSE PROFILE REPORTING TO SUPPLEMENT A1C: RATIONALE AND PRACTICAL IMPLEMENTATION. Hirsch, IB., Verderese, CA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11247041/

Best-Practice Perspectives on Improving Early Detection ... The basic metabolic panel (BMP) and comprehensive metabolic panel (CMP) are tests that measure substances in the blood. A CMP includes tests for albumin, ...

2. custommarketinsights.com custommarketinsights.com/report/comprehensive-metabolic-panel-testing-market/

Global Comprehensive Metabolic Panel Testing Market 2025 The Comprehensive Metabolic Panel Testing Market was valued at USD 12.41 Billion in 2025 and is expected to reach USD 27.86 Billion by 2034, at a CAGR of 8.47%.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11153288/

The metabolome as a diagnostic for maximal aerobic capacity ... The serum metabolome distinguishes high and low maximal aerobic capacity and has diagnostic potential for facilitating personalised medicine approaches.

4. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/22058-comprehensive-metabolic-panel-cmp

Comprehensive Metabolic Panel (CMP): What It Is & Results A comprehensive metabolic panel (CMP) is a blood test that measures proteins, enzymes, electrolytes, minerals and other substances in your body.

5. medlineplus.gov medlineplus.gov/lab-tests/comprehensive-metabolic-panel-cmp/

Comprehensive Metabolic Panel (CMP) A comprehensive metabolic panel (CMP) is a routine blood test that measures 14 different substances in a sample of your blood.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5485735/

Metabolic profiling of type 1 diabetes mellitus in children ... The present study demonstrates that metabolic profiling of plasma by 1 H-NMR spectroscopy allows to discriminate between T1DM patients and controls.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0168822723006708

Glycometabolic outcomes in adult type 1 diabetic patients ... This study aimed to evaluate glycometabolic outcomes in AID technology-naïve T1D patients after switching to Hybrid Closed Loop (HCL) and Advanced Hybrid ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6105320/

Type 1 Diabetes in Children and Adolescents: A Position ... Abnormal results from a random lipid panel should be confirmed with a fasting lipid panel. ... Neither long-term safety nor cardiovascular outcome efficacy ...

9. diabetesjournals.org diabetesjournals.org/care/article/28/8/2019/23775/Metabolic-Syndrome-in-Type-1-DiabetesAssociation

Metabolic Syndrome in Type 1 Diabetes The prevalence of metabolic syndrome was 31% in patients with good glycemic control, 36% in patients with intermediate glycemic control, and 51% ...