- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823406
Tissue-Specific Metabolic Reprogramming in Diabetic Complications (DP3)
Tissue-Specific Metabolic Reprogramming in Diabetic Complications. Glycemic Clamp Studies to Determine the Real Time Synthesis Rates of Glucose Derived Metabolites in Individuals With Type 1 Diabetes and Healthy Controls.
Study Overview
Status
Conditions
Detailed Description
Objective: To assess steady state and dynamic metabolite changes in subjects with type 1 diabetes with and without microvascular complications and to understand intrinsic differences from non-diabetics in metabolite levels and flux.
The hypothesis is that diabetic complications arise from tissue-specific metabolic reprogramming resulting in alterations in fuel utilization which lead to dysfunction of the tissue. To test this hypothesis, we will use sensitive and specific mass spectrometer based metabolomic analysis to measure steady state metabolite levels in plasma and urine from controls subjects and subjects with T1DM, without and with diabetic complications during euglycemic and hyperglycemic clamp studies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Group 1: T1DM subjects without complications:
Group 2: T1DM subjects with microalbuminuria . Group 3: T1DM subjects with advanced diabetes complications Group 4: Age-and-sex-matched healthy control subjects .
Inclusion Criteria:
General entry criteria:
Must have type 1 diabetes > 5 years duration. 18 years of age or older
Subjects in the microalbuminuria group will have a history of urinary microalbumin to creatinine ration between 30-300 m/g confirmed on repeat testing while the non-albuminuric group will have a value of less than 30 mg/g.
Subjects in advanced complications group will have confirmed Retinopathy, Peripheral and/or Autonomic Neuropathy and nephropathy.
Non diabetic individuals will be matched for age and gender and will have normal glucose tolerance, normal lipid metabolism, and normal blood pressure.
Exclusion Criteria:
Age less than 18 . Women of child-bearing potential who may be pregnant or lactating History of pancreas, kidney or liver transplant History of drug or alcohol use. History of cancer other than basal cell carcinoma or squamous cell skin cancer. Presence of a condition that in the opinion of the investigator would make it unlikely for the subject to complete the study.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Type 1 Diabetes no complications.
Each cohort group will be admitted to the Michigan Clinical Research Unit for Blood glucose Clamp studies.
Each subject will have a Euglycemic clamp (normal blood sugar clamp) for 4 hours and a hyperglycemic clamp (elevated blood sugar to 300) for 4 hours.
Once the subject is clamped, bloods and urine will be collected to assay for specific metabolomics and proteomic biomarkers.
We will perform the same clamps for each cohort.
|
|
Experimental: Type 1 Diabetes with microalbuminuria
Each cohort group will be admitted to the Michigan Clinical Research Unit for Blood glucose Clamp studies.
Each subject will have a Euglycemic clamp (normal blood sugar clamp) for 4 hours and a hyperglycemic clamp (elevated blood sugar to 300) for 4 hours.
Once the subject is clamped, bloods and urine will be collected to assay for specific metabolomics and proteomic biomarkers.
We will perform the same clamps for each cohort.
|
|
Experimental: Type 1 Diabetes with advanced complications.
Each cohort group will be admitted to the Michigan Clinical Research Unit for Blood glucose Clamp studies.
Each subject will have a Euglycemic clamp (normal blood sugar clamp) for 4 hours and a hyperglycemic clamp (elevated blood sugar to 300) for 4 hours.
Once the subject is clamped, bloods and urine will be collected to assay for specific metabolomics and proteomic biomarkers.
We will perform the same clamps for each cohort.
|
|
Experimental: Aged and sex matched healthy control volunteers
Each cohort group will be admitted to the Michigan Clinical Research Unit for Blood glucose Clamp studies.
Each subject will have a Euglycemic clamp (normal blood sugar clamp) for 4 hours and a hyperglycemic clamp (elevated blood sugar to 300) for 4 hours.
Once the subject is clamped, bloods and urine will be collected to assay for specific metabolomics and proteomic biomarkers.
We will perform the same clamps for each cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the levels of TCA cycle metabolites between groups during euglycemia and hyperglycemia
Time Frame: One time study visit /subject for an average of up to 24 h.
|
Investigators will perform 4 hour Euglycemic and 4 hr hyperglycemic glucose clamps on each subject once.
The Investigators will have 4 different groups of subjects.
At specific time points during the clamps, the investigators will draw blood samples for measurement of metabolic assays and flux .
The investigators will also collect spot urine samples for metabolic assay and flux.
|
One time study visit /subject for an average of up to 24 h.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rodica Pop-Busui, MD,PhD., University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00060967
- 1DP3DK094292-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Euglycemic clamp (normal blood sugar clamp) for 4 hours
-
Inova Health Care ServicesRecruitingPregnancy | Neonatal Hypoglycemia | Gestational Diabetes Mellitus, Class A2United States
-
Nantes University HospitalCompleted
-
Liverpool Heart and Chest Hospital NHS Foundation...Completed
-
Turku University HospitalUniversity Hospital TuebingenCompletedInsulin ResistanceFinland
-
Assistance Publique - Hôpitaux de ParisRecruitingIntrauterine Growth Restriction | Fetal Growth Restriction (FGR)France