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The Joslin Clinical Translational Research Core (CTRC) offers a safe and effective environment to conduct outpatient clinical research studies. The CTRC supports flexible, cost-effective staffing and specialty equipment/services for research studies in pediatric and adult age groups. With a focus on all forms of diabetes and their complications, the Joslin CTRC provides expertise and facilities that might not otherwise be readily available to individual investigators.

Core Leadership

Lori Laffel
Lori Laffel, MD, MPH
Senior Investigator
Chief, Pediatric, Adolescent, and Young Adult Section
Section Head, Clinical, Behavioral and Outcomes Research
Director, Clinical Translational Research Core
Professor of Pediatrics, Harvard Medical School
Jason Gaglia
Jason Gaglia, MD, MMSc
Assistant Investigator and Staff Physician
Section Head, Clinical, Behavioral and Outcomes Research
Director of Hood Center for the Prevention of Childhood Diabetes
Co-Director, Clinical Translational Research Core
Assistant Professor of Medicine, Harvard Medical School

Facilities

The CTRC is located on the third floor of the Joslin Diabetes Center and consists of ~5000 square feet of space, which includes patient reception and waiting area, six examination/treatment rooms, six infusion/procedures rooms (including a pediatric-focused procedure room), sample processing facility, USP-797 compounding area, diabetes technology download station, exercise research laboratory, and offices.

Selected CTRC Facilities
Fig 1. Selected CTRC Facilities.

 

 

 

 

 

 

 

 

 









Fig 1. Selected CTRC Facilities.

A, Waiting area and check-in desk.
B, Pediatric procedure room.
C, Adult exam room.
D, DEXA room.
E, Freezer room.
F, Compounding room
G, Processing Lab.
H, Aerobic exercise testing room.
I, Autoclave Room.

Services Provided

Consultations are provided by the Core Directors and staff to help investigators choose the most appropriate metabolic studies to address innovative research questions in human subjects. Core personnel assist investigators in selecting appropriate metabolic variables, biomarkers, recruitment strategies, and outcome measures, and offer guidance for methodology adaptation to human studies.

The CTRC provides consultations on data management and advice on database construction, quality checks, and maintenance, as well as on statistical analyses and interpretation of findings. The CTRC can also provide an independent clinical safety monitoring committee, external to the requesting clinical study, as part of a data and safety monitoring plan.

CTRC staff are available to perform blood draws, sample processing, coordination services, and medical monitoring for studies. The CTRC provides locked, temperature-controlled and monitored spaces for study drug storage, with local and remote alarms and auditable temperature records. The CTRC also has a USP 797 compliant compounding facility.

Measures of insulin action and systemic glucose homeostasis: Oral glucose tolerance test (OGTT), Mixed meal tolerance test (MMTT), stepped euglycemic hyperinsulinemic clamp studies including use of tracer techniques, hyperglycemic clamp, frequently sampled intravenous glucose tolerance test, and stepped hyperinsulinemic hypoglycemic clamp for the study of hypoglycemia and counter-regulation.

Measures of body composition: Anthropometrics, Dual-energy X-ray absorptiometry (DXA), and bioelectrical impedance analysis.

Measures of energy balance and expenditure, exercise capacity, and brown fat: Indirect calorimetry, muscle strength and endurance testing, VO2-peak during graded exercise capacity, training, and cooling vests.

Biopsies: Standardized operating procedures and training, sterilization and associated record retention for instruments.

Measures of renal function: Iohexol plasma disappearance for glomerular filtration rate (iGFR) and upcoming measurement of para-aminohippurate (PAH) clearance for renal plasma flow.

Neuropathy Testing: Specialty equipment available for neuropathy testing.

Measures of eye health and complications: refraction and visual acuity, dilated fundus examinations, color fundus photography, fluorescein angiography, optical coherence tomography (OCT), OCT angiography, adaptive optics scanning laser ophthalmoscopy, and electroretinography.

Browsable catalog of existing biospecimens and associated clinical data. The CTRC created a browsable catalog of 22 completed or ongoing biospecimen collections at Joslin with associated clinical data, through which DRC investigators can search for existing bio-specimens and/or linked clinical and molecular data that can be used through collaborations with the investigators who established the collections.

Table 1. DNA panels available from the CTRC

Phenotype

# samples

T1D, unrelated

912

T2D, unrelated

1600

Families with autosomal dominant T2D

540                 (33 families)

Families with early-onset autosomal dominant T2D

499                (52 families)

Metabolic studies with adipose and muscle tissue biopsies

344

Diabetic nephropathy

1200

T1D 50--year Medalists

695

Non-diabetic controls

400

Curated DNA collection. DNA samples from different groups of well-characterized individuals are available for studies involving human genetics. The Core repository houses the collection of ~6,000 DNA samples developed through the Molecular Phenotyping and Genotyping Core. Samples, some of which are linked to plasma and serum samples, are organized in seven panels (Table 1).
 

Induced pluripotent cells.  Protocols are available for skin-punch biopsy or phlebotomy to procure cells for induced pluripotent stem cell (iPSC) generation with consultation on experimental design and preparation of appropriate IRB documents along with assistance in patient accrual and consent, and help obtaining detailed medical records that are de-identified or coded prior to release to scientific collaborators who use  the derived cell lines. The Core’s browsable catalog can be used to locate >130 iPSC lines from individuals with diabetes (including T1D, T2D, and MODY), insulin resistance, related syndromes, and from control subjects, with accompanying phenotypic data.
 

 

 

 

 

 

CTRC-initiated collections from special populations. The CTRC supports two specific protocols for specimen and phenotype data collection.
 

  • The Joslin Registry and Biobank Study is a general Biorepository protocol that can be used to collect specific samples from populations of interest through Joslin-sponsored initiatives. Watch for annual solicitation for nominations of populations or families for study.
     
  • The Joslin Diabetes Characterization Study defines a process for identifying and studying individuals/family members with unusual forms of diabetes that have not been previously well characterized. Cases of unknown etiology or with unusual phenotype can be further evaluated for T1D, T2D, and other forms of diabetes under the protocol through study of affected individuals, and when possible, their family members, including the Molecular Phenotyping and Genotyping Core’s next-gen sequencing assay to evaluate for known mutations and diabetes-associated SNPs.

Requesting Services and Chargeback Rates

Visit Joslin’s iLab portal to request services and for information on chargebacks.

Remember to cite the DRC

If any of your research has been supported in full or in part by our Core, please acknowledge our NIH/NIDDK grant as follows: "Supported by the Clinical Translational Research Core of NIH P30 DK036836.

 

Contacts

Charlene Coneys, R.N.
CTRC Nurse Manager
Email: Charlene.coneys [at] joslin.harvard.edu (Charlene[dot]coneys[at]joslin[dot]harvard[dot]edu)
Phone: 617-309-2749 

Jason Gaglia, M.D., M.M.Sc.
Co-Director, Joslin CTRC
Email: Jason.gaglia [at] joslin.harvard.edu (Jason[dot]gaglia[at]joslin[dot]harvard[dot]edu)
Phone: 617-309-4214 

Lori Laffel, M.D., M.P.H
Director, Joslin CTRC
Email: lori.laffel [at] joslin.harvard.edu (lori[dot]laffel[at]joslin[dot]harvard[dot]edu)
Phone: 617-309-3480