Request for Funding
Medical Student Research Fellowship for Summer 2004
Mentor: Philip Raskin, M.D. and others
Department: Internal Medicine
Room number: G5.238
Mail Code: 8858
Phone number: 82017 / 72017
E-mail: philip.raskin@utsouthwestern.edu
Several Projects
Project I title: Preservation of beta-cell function in type 2 diabetes
Human subjects IRB approved project number (where applicable): 1003-623
Animal subjects IRB approved project number (where applicable): NA
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)
Brief Description of Project: The project is designed to evaluate beta-cell function longitudinally in newly diagnosed type 2 diabetic patients and compare the decline rate in a group of patients treated with insulin and metformin vs. triple oral antidiabetic regimen.
Students will get an introduction into clinical research. They will learn about recruitment of study volunteers, the conduct of a research protocol, data entry and hopefully, some preliminary data analysis.
Previous Research Activities or Publications with Medical Students:
Summer, 1990 (Grant Dorsey)
Summer, 1993 (Oscar Molina)
Summer, 1994 (Michael Morris, Matthew Myers, and Leland Wilfong)
Summer, 1995 (Jason Brown, Craig Simpson, David Sorley)
Summer, 2000
Project II title: Idiopathic Type 1 Diabetes: Pathogenesis and Progression
Idiopathic Type 1 diabetes, or non-autoimmune Type 1 diabetes is a relatively
frequent form of diabetes. It almost always occurs in minority individuals,
usually African-American people but also in individuals of Hispanic origin.
Patients with this form of diabetes usually present with the classical features
of typical Type 1, autoimmune diabetes, i.e., weight loss and ketoacidosis,
yet they have the phenotypic appearance of Type 2 diabetes, (older age, obesity,
etc). Treatment with insulin is usually required at diagnosis but after a variable
period of time many of these individuals can discontinue insulin therapy and
be treated with a diet and exercise program and/or oral anti-diabetic medications.
The specific aim of this project is the study of the natural history of individuals
with idiopathic Type 1 (non-autoimmune) diabetes, to demonstrate that idiopathic
Type 1 diabetes is a form of insulin deficient diabetes with progressive beta
cell failure that is not due to autoimmune destruction of beta cells and to
compare the effects of various treatments on the progression of the disease.
The design includes the study of insulin secretion and insulin sensitivity in-patients
with idiopathic Type 1 diabetes, with a comparison of their results with individuals
with autoimmune Type 1 diabetes and those with Type 2 diabetes. These studies
will be carried out in a cross-sectional manner on a group of patients in our
database, already identified and classified into one of these groups at least
four years after diagnosis. We also plan to identify another cohort of individuals
at diagnosis and follow the natural history of the disease over the subsequent
four to five years. Finally, a comparison of conventional treatment with insulin
or conversion to sulfonylureas in individuals with idiopathic Type 1 diabetes
will be done with the plan to study outcomes such as glycemic control, insulin
secretion, etc, relative to treatment.
We have had medical students from this program every year. Although very few
students "get a paper" from their summer work with us, I do think
most of our students enjoy the summer and get a brief introduction into patient
based clinical research. Whereas, a two month time period may be enough time
to complete a laboratory based project it is never sufficient to complete a
clinical one. Students who work with us learn how to identify and recruit patients
and to initiate a clinical research project. The other potential added value
for students who work with us that in the two months they can learn a lot about
diabetes. It is not unusual for our students to attend teaching rounds on the
diabetes inservice on a regular basis. This usuallay does not interfer with
their other work.
Project III title: "Gender and Ethnic Differences in Lipid Parameters
in Diabetes Mellitus" and "Menstrual Status, Hormonal Replacement
Therapy and Lipid Levels in Diabetes Mellitus"
Human subjects IRB approved project number (where applicable): NA
Animal subjects IRB approved project number (where applicable): NA
Project Type (patient-based research, animal-based research, or basic research;
this characterization is only to permit a general classification for grouping
similar types of projects)
Retrospective chart review
Brief Description of Project 1:
The first project is a continuation of a retrospective review of medical charts
of young diabetic individuals hospitalized at the University Diabetes Treatment
Center, at Parkland Health and Hospital System. The purpose of this review is
to compare the lipoprotein profile of young (ages 18-45 years) men and women
with diabetes and correlate their lipoprotein profile with body weight, gender,
duration of diabetes and glycemic control. Also, lipoprotein profile among ethnic
groups (non-Hispanic whites, Hispanics and African Americans) will be compared.
The ultimate purpose of this review is to confirm or not two previous findings:
(1) HDL-C levels were similar between genders and among ethnic groups, and (2)
HDL-C levels were indirectly associated with hemoglobin A1c levels in all groups.
The second project is a continuation of a retrospective review of medical charts
of premenopausal and postmenopausal women with diabetes hospitalized at the
University Diabetes Treatment Center, at Parkland Health and Hospital System.
The purpose of this review is to compare the lipoprotein profile of premenopausal
diabetic women, postmenopausal diabetic taking hormonal replacement therapy
and postmenopausal diabetic women not taking hormonal replacement therapy. The
lipoprotein profiles will be correlated with hemoglobin A1c, body weight, and
duration of diabetes. The ultimate purpose of this review is to confirm or not
two previous major findings: (1) HDL-C levels were higher in postmenopausal
women on hormonal replacement therapy, and (2) HDL-C were indirectly associated
with hemoglobin A1c levels.
Project IV title: "The effects of intensive insulin therapy on
cardiovascular risk factors in Hispanics with Type 2 diabetes mellitus"
Project Type (patient-based research, animal-based research, or basic research;
this characterization is only to permit a general classification for grouping
similar types of projects)
Patient-based
Brief Description of Project IV:
The goal of this five-year awarded project is to provide education, intensive
intervention and improve Type 2 diabetes control of Hispanics using insulin,
diet and exercise. Several cardiovascular risk factors will be correlated with
glycemic control and any change in these factors will be correlated with changes
in insulin dosage, glycemic control, anthropometric measurements and peripheral
insulin sensitivity. Also, these parameters will be compared between men and
women, and any gender similarities or differences established.
The medical student will have the opportunity to interview patients, understand
their cultural perspective of diabetes, deliver outpatient diabetes treatment
and education, and learn and perform the hyperinsulinemic clamp technique and
anthropometric measurements. Since the study is still on its initial phase,
baseline characteristics will only be compared.
Project V title: "Potential Causes of Weight Gain with Intensive Insulin and Combination Therapy in Type 2 Diabetes"
Human subjects IRB approved project number (where applicable): 0403-218
Animal subjects IRB approved project number (where applicable): n/a
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects) Patient-based research.
Brief Description of Project: The study is a prospective analysis of body changes after intensive insulin therapy has been initiated. The main question is: what is responsible for the weight gain that follows intensive glycemic control? The secondary question is: where does this weight goes to?
The subjects have poorly controlled type 2 diabetes. The measurement of body fat is done by underwater weighing. Glycosuria is measured by 24-hr urine collections. Appetite is measured by visual analog scales, while activity is estimated by a 7-day recall. Food diaries are obtained as well. Indirect calorimetry at fasting is performed to estimate resting energy expenditure. MRI of abdomen is performed to measure visceral fat. Blood is drawn as well for HbA1c (3 month average blood sugar), glucose, insulin, c-peptide, leptin, as well as liver and kidney function tests. The tests are repeated at 3 and 6 months.
Previous Research Activities or Publications with Medical Students:
Cristina Montalvo and Rodolfo García worked on this project last summer,
but the data collected was insufficient for presentation or publication.
Project VI title: Comparison of the Inhibitory Effects of Prolonged Hyperglycemia on Insulin Secretion in Idiopathic Type 1 and Type 2 Diabetes
Human subjects IRB approved project number (where applicable): 50
Animal subjects IRB approved project number (where applicable): NA
Project Type : Patient based
Brief Description of Project: This study compares insulin production between healthy volunteers, type 2 diabetes, and a third entity with classification problems known as atypical ketosis-prone diabetes. Our aim is to understand why this last group of diabetic individuals is prone to develop a hyperglycemic crisis known as Diabetic Ketoacidosis while typical type 2 diabetes is not.
This study involves 3 days of constant hyperglycemia, stimulation of insulin secretion by glucose and by the amino acid arginine, frequent clinical and biochemical monitoring during the hyperglycemic phase, and involvement with computer programs that translate C-peptide values to insulin secretion rates.
Atypical ketosis-prone diabetes has been mostly described in men from African origin, African, Afro-Caribbean, or African-American. Our target population consists of African-American men.
Project VII
Project title: The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects with Hypertension
Human subjects IRB approved project number (where applicable): 012004-038
Animal subjects IRB approved project number (where applicable):
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects) patient-based
Brief Description of Project: This is an open-label, randomized, 3-arm, parallel-group,
multicenter trial designed to assess the effects of olmesartan, losartan, and
atenolol on insulin sensitivity in subjects with features of the insulin resistance
syndrome, including hypertension and overweight/obesity. We hope to randomize
between 6 and 15 patients. There will be a 4-week placebo run-in and a 12-week
active treatment period. Visits are scheduled at weeks -4 (screening), -3, -2,
-1, 0 (randomization), 2, 4, 8, and 12. The primary efficacy variable is the
change in insulin sensitivity, as measured by M value derived from hyperinsulinemic-euglycemic
clamp procedures that will be performed at randomization and at the end of the
study. We will also perform oral glucose tolerance tests at weeks -4 and 12.
Previous Research Activities or Publications with Medical Students: none
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