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Tissue-Specific Metabolic Reprogramming in Diabetic Complications (DP3)

This study is currently recruiting participants.
Verified June 2017 by Rodica Pop-Busui, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823406
First Posted: April 4, 2013
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
  Purpose
We will perform blood sugar studies to assess changes in metabolic (biochemical processes that occur within us) profiles associated with high blood sugar and diabetes.

Condition Intervention
Type 1 Diabetes Mellitus Procedure: Euglycemic clamp (normal blood sugar clamp) for 4 hours Procedure: hyperglycemic clamp (elevated blood sugar to 300) for 4 hours

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Rodica Pop-Busui, University of Michigan:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Euglycemic clamp (normal blood sugar clamp) for 4 hours Procedure: hyperglycemic clamp (elevated blood sugar to 300) for 4 hours
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.
Procedure: Euglycemic clamp (normal blood sugar clamp) for 4 hours Procedure: hyperglycemic clamp (elevated blood sugar to 300) for 4 hours
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.
Procedure: Euglycemic clamp (normal blood sugar clamp) for 4 hours Procedure: hyperglycemic clamp (elevated blood sugar to 300) for 4 hours
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.
Procedure: Euglycemic clamp (normal blood sugar clamp) for 4 hours Procedure: hyperglycemic clamp (elevated blood sugar to 300) for 4 hours

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823406


Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cynthia D Plunkett, RN    734-936-8065    cplunket@umich.edu   
Contact: Rodica Pop-Busui, MD, PhD    734-763-3056    rpbusui@umich.edu   
Principal Investigator: Rodica Pop-Busui, MD,PhD.         
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rodica Pop-Busui, MD,PhD. University of Michigan
  More Information

Responsible Party: Rodica Pop-Busui, Associate Professor Internal Medicine, MEND Division, University of Michigan
ClinicalTrials.gov Identifier: NCT01823406     History of Changes
Other Study ID Numbers: HUM00060967
1DP3DK094292-01 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2013
First Posted: April 4, 2013
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases