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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