Less sugar and more of the sweet life: the Diabetes Prevention Program

Washington

The Diabetes Prevention Program (DPP) is a researh
study being conducted at twenty-five medical centers around the
country. Sponsored by the National Institutes of Health’s (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the program hopes to prove that type 2 diabetes can be
prevented by altering one’s lifestyle and/or medication.

“This is the first program of its type where we are actively
seeking to find a way to prevent a disease and not just treat it,” said
David Nathan, M.D., study chairman of the DPP and director of the
Diabetes Center at Massachusetts General Hospital in Boston.

Although the six-year study began last year, research sites are
still recruiting participants. In fact, participants will be recruited
for two more years.

Medlantic Clinical Research Center is collaborating on the project
with Howard University, the only historically Black college or
university involved in the study. Wayman Cheatham, M.D., from Howard
University School of Medicine’s Department of Endocrinology, codirects
the Washington, D.C., study with Robert Ratner, M.D, head of Medlantic.

Nationally, 4,000 volunteers will be screened for the program and
they must be suffering from a condition known as impaired glucose
tolerance (IGT). People with IGT have blood sugars which are higher
than normal but not high enough to be considered diabetes. A major risk
factor for type 2 diabetics, approximately 21 million Americans have
IGT. However, according to NIDDK, most them do not know they have the
condition.

The program is designed for people with IGT who have fasting
glucose levels between 95 and 125. Fasting glucose levels are
blood-sugar measurements taken after a person has not eaten for twelve
hours. Fasting glucose levels above 125 are considered diabetic; levels
between 110 and 125 are considered Impaired Fasting Glucose; levels
between 70 and 110 are considered normal; and levels below 70 are
considered too low, or hypoglycemic.

According to Gretchen Youssef, program coordinator of the DPP study
being conducted by Howard and Medlantic, it was decided that for the
sake of the study, the impaired fasting glucose level should be lowered
to 95. That is because someone with IGT may have a fasting glucose
level of under 110 and a two-hour glucose level – taken two hours after
a meal – of more than 150, which is within the range for two-hours IGT
(from 141 to 190).

Of the 4,000 volunteers wanted for the program, it is planned that
half of them will be women and half of them will be minorities. One
quarter of the study group I will be sixty-five or older.

Its Importance

The significance of the research has wide-ranging health
implications. Diabetics have trouble processing sugars within their
bodies because insulin, the substance that breaks down sugar molecules
in the blood, is either being produced in insufficient quantities or
being ignored by the body. When sugars are not sufficiently broken
down, the blood thickens and flows at a slower rate through the
circulatory system. The thicker blood and slower rate of circulation
affect the ability of the circulatory system to deliver oxygen to
individual cells.

There are two main types of diabetes Type 1 diabetics are
insulin-dependent and usually become afflicted with the disease during
childhood or adolescence. They comprise between 5 percent and 10
percent of all those with diabetes. Type 2 diabetics do not necessarily
require insulin and usually become afflicted after the age of forty.

After several years, diabetics begin developing other problems —
heart disease, stroke, high blood pressure, blindness, nerve damage,
and kidney failure. Circulation problems related to diabetes can also
result in the amputation of toes, feet, and legs. Furthermore, males
can experience impotency as a result of the disease.

Finding a cure for type 2 diabetes can alleviate many of those
complications. And if it can be shown that the disease can be
prevented, insurance companies may be more willing to cover the cost of
medication, maintenance, and education programs for diabetics.

“That’s why I’m really excited about the trial,” David Schade,
M.D., professor of internal medicine at the University of New Mexico
(UNM), told the Albuquerque journal last summer. “In five years, if I’m
right, we’ll see everybody preventing diabetes because it’s cost
effective.”

Diabetes maintenance for type 2 individuals not using insulin
involves self-testing for blood-sugar levels, diets low in sugar and
fat, exercise, and – although not always – medication.

According to NIDDK, the number of Americans with type 2 diabetes
has increased to 16 million — 8 million diagnosed and another 8
million estimated to have the disease. Officials with the Center for
Disease Control and Prevention (CDC) in Atlanta said, on October 31,
that the number of persons diagnosed with diabetes has increased
sixfold in forty years. In 1958, 1.6 million Americans had diabetes; in
1997 that number rose to 10 million. The CDC numbers include both type
1 and type 2 diabetics.

Since 1983, the prevalence of diabetes in this country has
increased by 50 percent, with 600,000 new cases currently diagnosed
each year, according to NIDDK. As a result, the health care costs of
diabetes account for 15 percent ($92.6 billion) of total U.S. health
care expenses each year.

“This country has seen a tripling of diabetes over the past thirty
years, and as baby boomers continue to age, gain weight, and remain
inactive, type 2 diabetes will only become more common, more costly and
more destructive,” said Frank Vinicor, M.D., M.P.H., president of the
American Diabetes Association (ADA).

Additionally, diabetes is the nation’s seventh leading cause of
death, contributing to approximately 187,800 deaths in 1995, according
to CDC.

Type 2 diabetes is a particularly troubling disease for minorities.
Diabetes in America, an NIH publication, reveals that while the
national rate has tripled in the last thirty years, the percentage
among Whites has only doubled. One in four African American women over
the age of fifty-five have the disease, which is double the rate of
White women of the same age. Diabetes rates in Cuban Americans are 50
to 60 percent higher than White Americans; and among Mexican Americans
and Puerto Ricans, the rate is 110 to 120 percent higher. Three times
as many Native Americans die because of complications from diabetes as
other Americans. And prevalence rates for diabetes are two times
greater in Asian Americans than in Whites.

As to why minorities are so prone to diabetes: “That’s the $64,000
question, and no one has been able to answer it,” said Ken Inchausti of
the ADA. “No one has been able to singularly point to why minorities
are so disproportionately predisposed to diabetes.”

Medlantic’s Approach

Of the sixty-one participants at Ratner’s Medlantic Center in
mid-September, thirty-five are African Americans, one is Native
American, one is Cuban American, and the rest are White.

Medlantic, which is expected to study 187 volunteers, conducted
6,000 community screenings and 563 screenings at the center to get its
sixty-one participants. The community screenings involve finger-stick
blood testing. If IGT is suspected, the applicant is asked to go to the
Medlantic center for another screening — this one lasting
approximately two hours.

If blood sugar counts are higher than IGT levels, applicants are
urged to have the findings re-checked by their personal physicians.
Applicants who have already been diagnosed with diabetes or whose
blood-sugar levels are too high will not be invited to participate.

Jane Doe, a lawyer from Chevy Chase, Maryland, who wishes to remain
anonymous because of worries about her health insurance provider, is
Black, forty-three years old, and thirty pounds overweight. She
received information on the program in the mail and entered the study
because she saw the harm type 2 diabetes has caused her
seventy-year-old aunt, who was diagnosed with the disease last year.

“I also have friends who have had it creep up on them,” she said.
“I figured there was nothing to lose by taking an initial test and I
called.”

Qualified participants are then randomly put into one of four
groups. One group focuses intensively on lifestyle and the three other
groups work with medication.

Readjusting Each Experience

Despite the groupings, however, “Everyone here will have a one-on-one experience,” says Ratner.

While all groups will deal with lifestyle changes, the “intensive”
lifestyle group demands rigorous attention to detail. Members of this
group must lose 7 percent of their body weight within six months an
then maintain that reduction throughout the study. They will be
expected to make a “moderate” change in their diet and caloric intake,
and a “moderate” increase I in their exercise regimens. They will be
taught new cooking techniques and how to dine out within the
restrictions of their diets.

They will also have to be monitored at the center three times a
week for the first sixteen weeks. After that, the frequency which they
report to the center will depend on how they do with their regimens.

“We are not here to tell people what they have to do,” explains
Ratner. “We try to establish mutually determined goals. We want to make
the adjustments acceptable to the patients. We are determined to be
sensitive to the exercise and food choices of the patients. If a
patient is a vegetarian, we will work within the constraints of a
vegetarian diet. If someone has particular ethnic food choices, we have
to deal with the foods that they wish to deal with.

“The same applies to the exercise component,” he continues. “We
look for activities that the patient can do and is willing to do. It
makes no sense telling someone to swim everyday if they don’t have
access to a swimming pool.”

Medication and Trust

The other three groups are treated with medication in conjunction
with a healthy lifestyle. Participants in these groups are taking part
in a double-blind randomized trial. One group will take a medication
called metformin with a placebo (a medicinally inactive preparation) of
the medication called troglitazone. Another group will take
troglitazone with a placebo of metformin. The final group will take
placebos of both medications. All medications will be taken in pill
form.

Although metformin and troglitazone are the medications chosen for
the study, doctors have been using sulfonylurea drugs to treat diabetes
since the 1950s. However, a side effect of sulfonylurea drugs —
hypoglycemia, or low blood sugar — was, says Ratner, the determining
factor in the decision not to use those medications in the study.

Researchers will be actively looking for side effects from the
chosen medication, according to Ratner, in order to minimize their
effects on the patients.

Jane Doe is in one of the pill-taking groups. Although she says
that she would never do any “drug testing,” she has no problems with
the medication she is given at Medlantic.

“I checked the medication with my doctor,” she said, “and as it happened, metformin is being taken by my aunt.”

In fact, everything checked out by Jane Doe – who did master’s work
in Public Health Policy at Harvard – met with her satisfaction.

“This study is put together very well,” she says. “The staff is very professional and courteous.”

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RELATED ARTICLE: Diabetes Prevention Program Participating Medical Centers

Albert Einstein College of Medicine
(The Bronx, N.Y.,) 718-405-8274
Howard University, in collaboration with the
Medlantic Clinical Research Center
(Washington, D.C.) 202-675-2082
Indiana University School of Medicine
(Indianapolis) 317-278-0854
Johns Jopkins University Pro Health
(Baltimore, Md.) 410-281-2990
Joslin Diabetes Center (Boston) 617-735-1907
Massachusetts General Hospital (Boston) 317-724-3197
Northern Navajo Medical Center (Shiprock, N.M.) 505-368-3055
Northwestern University Medical (Chicago) 312-902-9500
Pennington Biomedical Research Center
(Baton rouge, La.) 504-763-2596
Pueblo of Zuni (Zuni, N.M.) 505-782-4555
St. Luke's-Roosevelt Hospital (New York City) 212-523-8989
The Southwest American Indian Center for Diabetes
Prevention (Phoenix, Arix.) 602-200-5338
Thomas Jefferson University Jefferson Medical 215-955-0444
College Philadelphia)
University of California-San Diego 619-642-0225
University of Chicago Hospitals 773-702-9655
University of Colorado (Denver) 303-315-7854
University of Hawaii (Honolulu) 808-537-7155
University of Miami School of Medicine 305-243-3411
University of New Mexico Health Sciences Center
(Albuquerque) 505-272-8269
University of Pittsburgh Medical Center 412-383-2194
University of Southern California (Los Angeles) 213-226-7959
University of Tennessee-Memphis 901-448-8400
University of Texas Health Science Center
(San Antonio) 210-567-4799
University of Washington (Seattle) 206-764-2768
Washington University School of Medicine
(St. Louis, No.) 1-800-434-7465

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