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Glucose Metabolism in Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02922296
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Victor Gordeuk, University of Illinois at Chicago

Tracking Information
First Submitted Date July 31, 2016
First Posted Date October 4, 2016
Last Update Posted Date November 24, 2021
Study Start Date May 1, 2015
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2016)
Metabolic status of adult SCD subjects [ Time Frame: through study completion, approximately one year after subject participation ]
The investigator will use the ATP III guidelines for definition of metabolic syndrome. A combination of any three of the following criteria will lead to the designation of metabolic syndrome:
  • waist circumference >102 cm (men) or >88 cm (women)
  • triglycerides ≥150 mg/dL
  • HDL cholesterol <40 mg/dL (men) or <50 mg/dL (women)
  • blood pressure ≥130/≥85 mg/dL (or recorded diagnosis of hypertension and use of antihypertensives)
  • fasting glucose ≥110 mg/dL (or diagnosis of diabetes and use of anti-diabetic medications)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2016)
Genetic and genomic predictors in SCD subjects [ Time Frame: through study completion, approximately one year after subject participation ]
This will be accomplished by DNA linkage analysis and/or mutation analysis. In addition RNA will be isolated from from PBMCs and fractions of platelets, granulocytes and reticulocytes. The investigators will analyze the expression of transcripts to determine if alterations can explain the clinical observations.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Glucose Metabolism in Sickle Cell Disease
Official Title Glucose Metabolism in Sickle Cell Disease
Brief Summary

The purpose of the study is to better understand how the body handles sugars glucose and fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain persons at risk to develop diabetes. This understanding may help us to find new treatments to control blood sugar and prevent diabetes in people with and without sickle cell disease (SCD).

In this research, DNA and RNA will be isolated from blood cells. DNA will be used to find genes that cause or protect from diabetes, high cholesterol and high triglyceride, and RNA will be used for studies designed to find out how genes are doing their job of eventually producing proteins.

Detailed Description

Sickle cell disease (SCD) is due to homozygosity for a Glu6Val mutation in HBB (sickle cell anemia; hemoglobin SS) or to compound heterozygous forms like hemoglobin SC disease and hemoglobin S-β thalassemia. Past studies suggested a low prevalence of diabetes in patients with SCD.10 Improvements in treatment and care have increased the life span of patients. This, along with the wide availability of high calorie diets and increasing adiposity in SCD raises that possibility that the prevalence of diabetes is increasing in SCD. Our study is designed to characterize the changes in metabolism that occur in sickle cell disease and to identify clinical, genetic and genomic risk factors for the development of diabetes. Our hypothesis is that non-overweight subjects with SCD have relative protection from diabetes and metabolic syndrome, but that those individuals who do become overweight have a dramatic increase in the rates of diabetes and metabolic syndrome. Lean SCD subjects will not have simply a neutral, but an overtly anti-diabetic phenotype (e.g. better glucose tolerance and lower metabolic syndrome markers). The two main study aims are as follows; Aim 1. Define the metabolic status of adult SCD subjects according to normal or increased BMI.

Aim 2. Determine genetic and genomic predictors of overweight, metabolic syndrome and diabetes in SCD subjects.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples will be stored temporarily in the laboratory of the Principal Investigator at the University of Illinois at Chicago, long term storage of specimens will be at the UIC Biobank. The research data will be stored in a locked file cabinet in the PI's research office. The patient's name or other identifying data will not be revealed, except to those directly involved in this study.
Sampling Method Non-Probability Sample
Study Population Adult sickle cell disease subjects, with or without diabetes.
Condition
  • Sickle Cell Disease
  • Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 29, 2016)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Major sickling genotype (hemoglobin SS, Sbeta0-thalassemia, SOarab, SDpunjab)
  • Age >35 years
  • BMI <25 kg/m2 or >26 kg/m2
  • Steady state, defined as >two weeks from a hospitalization for vaso-occlusive crisis, infection or surgery and not requiring immediate parenteral medication for pain control
  • Fasting state (>8 hours since ingesting food or medication for diabetes)

Exclusion Criteria:

  • Patients receiving insulin therapy
  • Acute inflammatory or infectious illness or injury
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02922296
Other Study ID Numbers 2015-0366
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Victor Gordeuk, University of Illinois at Chicago
Study Sponsor University of Illinois at Chicago
Collaborators Not Provided
Investigators
Principal Investigator: Victor Gordeuk, MD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date November 2021