Diabetic Retinopathy Occurs in Pre-Diabetes

12 Jun, 2005, 01:00 ET from American Diabetes Association

    SAN DIEGO, June 12 /PRNewswire/ -- Diabetic retinopathy has been found in
 nearly 8 percent of pre-diabetic participants in the Diabetes Prevention
 Program (DPP), according to a report presented today at the American Diabetes
 Association's 65th Annual Scientific Sessions.  Diabetic retinopathy was also
 seen in 12 percent of participants with type 2 diabetes who developed diabetes
 during the DPP.  No other long-term study has evaluated retinopathy in a
 population so carefully examined for the presence or development of type 2
 diabetes.
     "These findings reinforce the recommendation that patients with newly
 diagnosed type 2 diabetes should be screened for retinopathy," said Emily
 Chew, M.D., of the National Eye Institute, the part of the National Institutes
 of Health (NIH) under the U.S. Department of Health and Human Services that
 funded the study.  "We advise good control of blood glucose, blood pressure,
 and cholesterol as well as regular eye exams," she added.
     "Previous studies have not accurately defined when type 2 diabetes begins,
 so our understanding of the onset of diabetic eye disease has been limited.
 Now we know that diabetic retinopathy does occur in pre-diabetes.  We're also
 seeing it early in the course of diabetes -- within an average of 3 years
 after diagnosis," noted Richard Hamman, M.D., DrPH, professor and chair,
 Department of Preventive Medicine and Biometrics, University of Colorado
 School of Medicine, and vice chair of the DPP.  "This adds to our
 understanding of the development of retinopathy and suggests that changes in
 the eye may be starting earlier and at lower glucose levels than we previously
 thought."
     Pre-diabetes is a condition in which blood glucose levels are higher than
 normal but not high enough for a diagnosis of diabetes.  The condition is
 sometimes called "impaired fasting glucose (IFG)" or "impaired glucose
 tolerance (IGT)," depending on the test used to diagnose it.  People with pre-
 diabetes have an increased risk of developing type 2 diabetes, heart disease,
 and stroke.
     Diabetic retinopathy, which begins with changes in the small vessels in
 the back of the eye, often leads to loss of vision.  Regular eye examinations
 to diagnose retinopathy are recommended for patients with diabetes because
 treatment with laser photocoagulation can often prevent blindness in more
 advanced cases.   Diabetic retinopathy is still the most common cause of
 blindness in adults.  (For more information about diabetic retinopathy, see
 NEI's Diabetic Retinopathy:  What you should know
 http://www.nei.nih.gov/health/diabetic/retinopathy.asp).
     "Certain retinopathy lesions are considered indicative of the presence of
 diabetes because they are the first retinal changes to develop in this
 disease," explained Dr. Hamman.  "Although the retinopathy seen in the DPP
 participants was at a very early stage and did not affect vision, eye changes
 typical for diabetes were found in 8 percent of our study population before
 they developed diabetes.  These observations may lead diabetes experts to
 reconsider the diagnostic thresholds used to define diabetes, which are based
 on levels of blood glucose associated with the development of eye, nerve and
 kidney complications of diabetes."
     DPP study chair David Nathan, M.D., of Massachusetts General Hospital,
 pointed out that the retinopathy results are based on a random sample of only
 12 percent of DPP participants, all of whom had impaired glucose tolerance, a
 form of pre-diabetes, when the study began.  "These initial findings confirm
 what other studies have suggested.  The complications of diabetes may begin
 before diabetes is diagnosed, at least by the current-day standards," he
 explained.  "Ideally, an expanded study of the remaining 88 percent of DPP
 Outcome Study participants might enable us to define more appropriate
 diagnostic thresholds."
     About 18.2 million Americans have diabetes, a group of serious diseases
 marked by high blood glucose levels that result from defects in the body's
 ability to produce and/or use insulin.  Diabetes can lead to severely
 debilitating or fatal complications, such as heart disease, blindness, kidney
 disease, and amputations.  It is the fifth leading cause of death by disease
 in the United States.  Type 2 diabetes, which accounts for up to 95 percent of
 all diabetes cases, involves insulin resistance -- the body's inability to
 properly use its own insulin.  It usually occurs in overweight adults, but it
 has increasingly been seen in obese children and teens in recent years.
     About 40 percent of U.S. adults ages 40 to 74 -- 41 million people -- have
 abnormal blood glucose levels without having diabetes.  Many will develop type
 2 diabetes in the next 10 years.  (In the DPP, about 10 percent of
 participants in the placebo group developed diabetes each year.)  Once a
 person has type 2 diabetes, the risk of heart and blood vessel disease is 2 to
 4 times that of people without diabetes.
 
     DIABETES PREVENTION PROGRAM
     The Diabetes Prevention Program was a major clinical trial in 3,234 people
 with impaired glucose tolerance.  The study's main results were announced in
 2001 and reported in the Feb. 7, 2002 issue of the New England Journal of
 Medicine:  Losing 5 to 7 percent of body weight through diet and a modest,
 consistent increase in physical activity (e.g., walking 5 days a week 30
 minutes a day) lowered the incidence of type 2 diabetes by 58 percent.
 Treatment with metformin, an oral drug commonly used to treat diabetes,
 reduced the chances of developing diabetes by 31 percent.
     The DPP was sponsored by the National Institute of Diabetes and Digestive
 and Kidney Diseases (NIDDK) and co-funded by other components of the NIH, the
 Centers for Disease Control and Prevention, and the Indian Health Service.
 The American Diabetes Association provided additional funding.  Sources of
 corporate support included Bristol-Myers Squibb, Parke-Davis, Merck and
 Company, Merck Medco, Hoechst Marion Roussel, Sankyo, Lifescan, Lipha
 Pharmaceuticals, Slimfast, Nike, and Health-O-Meter.
     About 90 percent of DPP participants continue to be followed closely in
 the DPP Outcomes Study to examine the longer-term impact of the original
 treatment interventions.  All participants are given access to quarterly
 lifestyle group sessions, while those in the original intensive lifestyle
 group have access to additional lifestyle activities to help them stay on
 track.  The participants originally assigned to metformin therapy continue to
 have access to the drug.
 
     RETINOPATHY FINDINGS
     Three hundred two, or about 12 percent, of the DPP Outcome Study
 participants who had not developed diabetes during the study, and 588 of 876
 participants who had developed diabetes, were selected to participate in the
 retinopathy study, funded by the NEI.  To detect diabetic retinopathy, an
 evaluation of the fundus (inner lining of the eye) was performed with a
 special camera that provides a detailed look at the retina.  Small changes in
 the vessels, called microaneurysms and hemorrhages, signal the development and
 degree of retinopathy severity.
     Participants with pre-diabetes and retinopathy typically had a small
 number of microaneurysms in the eye characteristic of early, mild retinopathy
 that is not yet linked to vision loss.  Those who had developed diabetes in
 the previous 1 to 5 years had slightly more severe retinopathy.  Higher
 average blood glucose levels and higher blood pressure were associated with
 the risk of developing retinopathy in the new-onset diabetic patients, similar
 to previous findings in people with longstanding diabetes who develop
 retinopathy.
     In its "Be Smart About Your Heart: Control the ABCs of Diabetes" campaign,
 the National Diabetes Education Program (NDEP) (http://www.ndep.nih.gov/),
 jointly sponsored by the NIH, the Centers for Disease Control and Prevention,
 and 200 partner organizations including the American Diabetes Association
 (ADA), encourages people with diabetes to control their blood glucose as well
 as their blood pressure and cholesterol.  By keeping all three as close to
 normal as possible, people with diabetes can live long, healthy lives.
     NDEP's "Small Steps.  Big Rewards.  Prevent Type 2 Diabetes" campaign
 gives tips on lifestyle changes to prevent or delay type 2 diabetes.
 
     The American Diabetes Association is the nation's leading voluntary health
 organization supporting diabetes research, information and advocacy.  Founded
 in 1940, the Association has offices in every region of the country, providing
 services to hundreds of communities.  For more information, please call the
 American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit
 http://www.diabetes.org.  Information from both these sources is available in
 English and Spanish.
 
     Late Breaking Clinical Trials Symposium
 
 

SOURCE American Diabetes Association
    SAN DIEGO, June 12 /PRNewswire/ -- Diabetic retinopathy has been found in
 nearly 8 percent of pre-diabetic participants in the Diabetes Prevention
 Program (DPP), according to a report presented today at the American Diabetes
 Association's 65th Annual Scientific Sessions.  Diabetic retinopathy was also
 seen in 12 percent of participants with type 2 diabetes who developed diabetes
 during the DPP.  No other long-term study has evaluated retinopathy in a
 population so carefully examined for the presence or development of type 2
 diabetes.
     "These findings reinforce the recommendation that patients with newly
 diagnosed type 2 diabetes should be screened for retinopathy," said Emily
 Chew, M.D., of the National Eye Institute, the part of the National Institutes
 of Health (NIH) under the U.S. Department of Health and Human Services that
 funded the study.  "We advise good control of blood glucose, blood pressure,
 and cholesterol as well as regular eye exams," she added.
     "Previous studies have not accurately defined when type 2 diabetes begins,
 so our understanding of the onset of diabetic eye disease has been limited.
 Now we know that diabetic retinopathy does occur in pre-diabetes.  We're also
 seeing it early in the course of diabetes -- within an average of 3 years
 after diagnosis," noted Richard Hamman, M.D., DrPH, professor and chair,
 Department of Preventive Medicine and Biometrics, University of Colorado
 School of Medicine, and vice chair of the DPP.  "This adds to our
 understanding of the development of retinopathy and suggests that changes in
 the eye may be starting earlier and at lower glucose levels than we previously
 thought."
     Pre-diabetes is a condition in which blood glucose levels are higher than
 normal but not high enough for a diagnosis of diabetes.  The condition is
 sometimes called "impaired fasting glucose (IFG)" or "impaired glucose
 tolerance (IGT)," depending on the test used to diagnose it.  People with pre-
 diabetes have an increased risk of developing type 2 diabetes, heart disease,
 and stroke.
     Diabetic retinopathy, which begins with changes in the small vessels in
 the back of the eye, often leads to loss of vision.  Regular eye examinations
 to diagnose retinopathy are recommended for patients with diabetes because
 treatment with laser photocoagulation can often prevent blindness in more
 advanced cases.   Diabetic retinopathy is still the most common cause of
 blindness in adults.  (For more information about diabetic retinopathy, see
 NEI's Diabetic Retinopathy:  What you should know
 http://www.nei.nih.gov/health/diabetic/retinopathy.asp).
     "Certain retinopathy lesions are considered indicative of the presence of
 diabetes because they are the first retinal changes to develop in this
 disease," explained Dr. Hamman.  "Although the retinopathy seen in the DPP
 participants was at a very early stage and did not affect vision, eye changes
 typical for diabetes were found in 8 percent of our study population before
 they developed diabetes.  These observations may lead diabetes experts to
 reconsider the diagnostic thresholds used to define diabetes, which are based
 on levels of blood glucose associated with the development of eye, nerve and
 kidney complications of diabetes."
     DPP study chair David Nathan, M.D., of Massachusetts General Hospital,
 pointed out that the retinopathy results are based on a random sample of only
 12 percent of DPP participants, all of whom had impaired glucose tolerance, a
 form of pre-diabetes, when the study began.  "These initial findings confirm
 what other studies have suggested.  The complications of diabetes may begin
 before diabetes is diagnosed, at least by the current-day standards," he
 explained.  "Ideally, an expanded study of the remaining 88 percent of DPP
 Outcome Study participants might enable us to define more appropriate
 diagnostic thresholds."
     About 18.2 million Americans have diabetes, a group of serious diseases
 marked by high blood glucose levels that result from defects in the body's
 ability to produce and/or use insulin.  Diabetes can lead to severely
 debilitating or fatal complications, such as heart disease, blindness, kidney
 disease, and amputations.  It is the fifth leading cause of death by disease
 in the United States.  Type 2 diabetes, which accounts for up to 95 percent of
 all diabetes cases, involves insulin resistance -- the body's inability to
 properly use its own insulin.  It usually occurs in overweight adults, but it
 has increasingly been seen in obese children and teens in recent years.
     About 40 percent of U.S. adults ages 40 to 74 -- 41 million people -- have
 abnormal blood glucose levels without having diabetes.  Many will develop type
 2 diabetes in the next 10 years.  (In the DPP, about 10 percent of
 participants in the placebo group developed diabetes each year.)  Once a
 person has type 2 diabetes, the risk of heart and blood vessel disease is 2 to
 4 times that of people without diabetes.
 
     DIABETES PREVENTION PROGRAM
     The Diabetes Prevention Program was a major clinical trial in 3,234 people
 with impaired glucose tolerance.  The study's main results were announced in
 2001 and reported in the Feb. 7, 2002 issue of the New England Journal of
 Medicine:  Losing 5 to 7 percent of body weight through diet and a modest,
 consistent increase in physical activity (e.g., walking 5 days a week 30
 minutes a day) lowered the incidence of type 2 diabetes by 58 percent.
 Treatment with metformin, an oral drug commonly used to treat diabetes,
 reduced the chances of developing diabetes by 31 percent.
     The DPP was sponsored by the National Institute of Diabetes and Digestive
 and Kidney Diseases (NIDDK) and co-funded by other components of the NIH, the
 Centers for Disease Control and Prevention, and the Indian Health Service.
 The American Diabetes Association provided additional funding.  Sources of
 corporate support included Bristol-Myers Squibb, Parke-Davis, Merck and
 Company, Merck Medco, Hoechst Marion Roussel, Sankyo, Lifescan, Lipha
 Pharmaceuticals, Slimfast, Nike, and Health-O-Meter.
     About 90 percent of DPP participants continue to be followed closely in
 the DPP Outcomes Study to examine the longer-term impact of the original
 treatment interventions.  All participants are given access to quarterly
 lifestyle group sessions, while those in the original intensive lifestyle
 group have access to additional lifestyle activities to help them stay on
 track.  The participants originally assigned to metformin therapy continue to
 have access to the drug.
 
     RETINOPATHY FINDINGS
     Three hundred two, or about 12 percent, of the DPP Outcome Study
 participants who had not developed diabetes during the study, and 588 of 876
 participants who had developed diabetes, were selected to participate in the
 retinopathy study, funded by the NEI.  To detect diabetic retinopathy, an
 evaluation of the fundus (inner lining of the eye) was performed with a
 special camera that provides a detailed look at the retina.  Small changes in
 the vessels, called microaneurysms and hemorrhages, signal the development and
 degree of retinopathy severity.
     Participants with pre-diabetes and retinopathy typically had a small
 number of microaneurysms in the eye characteristic of early, mild retinopathy
 that is not yet linked to vision loss.  Those who had developed diabetes in
 the previous 1 to 5 years had slightly more severe retinopathy.  Higher
 average blood glucose levels and higher blood pressure were associated with
 the risk of developing retinopathy in the new-onset diabetic patients, similar
 to previous findings in people with longstanding diabetes who develop
 retinopathy.
     In its "Be Smart About Your Heart: Control the ABCs of Diabetes" campaign,
 the National Diabetes Education Program (NDEP) (http://www.ndep.nih.gov/),
 jointly sponsored by the NIH, the Centers for Disease Control and Prevention,
 and 200 partner organizations including the American Diabetes Association
 (ADA), encourages people with diabetes to control their blood glucose as well
 as their blood pressure and cholesterol.  By keeping all three as close to
 normal as possible, people with diabetes can live long, healthy lives.
     NDEP's "Small Steps.  Big Rewards.  Prevent Type 2 Diabetes" campaign
 gives tips on lifestyle changes to prevent or delay type 2 diabetes.
 
     The American Diabetes Association is the nation's leading voluntary health
 organization supporting diabetes research, information and advocacy.  Founded
 in 1940, the Association has offices in every region of the country, providing
 services to hundreds of communities.  For more information, please call the
 American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit
 http://www.diabetes.org.  Information from both these sources is available in
 English and Spanish.
 
     Late Breaking Clinical Trials Symposium
 
 SOURCE  American Diabetes Association