Transcript DIABETES and its prevention - Healing Across the Divides

DIABETES and its prevention!!!
Norbert Goldfield, M.D.
Executive Director
Healing Across the Divides, Inc
Diabetes Is Associated with
Serious Health Consequences
• It is a major risk factor for coronary heart disease
(CHD) and stroke. In fact, the vast majority of
diabetic patients die of cardiovascular
complications. Diabetes is also the leading cause
of blindness, kidney failure, and nontraumatic
amputations, resulting from microvascular
complications. The economic toll of diabetes is
enormous. For example, in 2002, direct medical
and treatment costs and indirect costs due to
diabetes-related disability and mortality in the
United States exceeded $132 billion (3)
Are Type 2 diabetic patients offered
adequate foot care?
The role of physician and patient
characteristics-
Diabetes- General Facts
• 15.7 million people have diabetes:
• 10.3 million diagnosed (= a sixfold increase over
the past 40 years)
• 5.4 million undiagnosed
• ➤ 798,000 new cases diagnosed per year
• ➤ 7th leading cause of death in the U.S.
Diabetes Disproportionately Affects
Minority Populations
• ➤ Native Americans
• Overall prevalence of Type 2 diabetes in
Native Americans is 12.2%, compared to
5.2% of the general population. In some
tribes, 50% of the population has diabetes.
Self-Management Goals
• Identify self-management tools, including the
following:
– an action plan that includes goals and describes
behavior (e.g., increasing activity by walking 15
minutes 3 times per week)
– A review of the patient’s personal barriers (e.g., too
busy to exercise)
– Steps to overcome barriers
– The patient’s confidence level (e.g., on a scale of 1 to
10, how confident are you that you can meet your
goals?)
– follow-up plan
N Engl J Med, Vol. 344, No. 18
·
May 3, 2001
·
PREVENTION OF TYPE 2
DIABETES MELLITUS BY
CHANGES IN LIFESTYLE
AMONG SUBJECTS WITH
IMPAIRED GLUCOSE
TOLERANCE
The Diabetes Prevention Program
(DPP)
Description of lifestyle intervention
THE DIABETES PREVENTION
PROGRAM (DPP) RESEARCH
GROUP – D Nathan
Diabetes Control and
Complications Trial (DCCT)
Long term study showed benefits of intensive
metabolic control in patients with type 1
diabetes; lowering hemoglobin A(HbA) to
7%produced significant reduction (=75%)
in risk for complications (eye, kidney and
nervous system)
Treatment Protocol
Medications (eg, sulfonylure, metformin, or
insulin) added sequentially to treatment
regimens once failure occurred as indicated
by rising levels of blood glucose (BG)
United Kingdom prospective
Diabetes Study UKPDS
Patients had initial levels of HbA of 7%, 1%
difference maintained between groups
(intensive therapy vs. standard therapy); in
all patients, disease worsened metabolically
with time (insulin resistance worsened,
insulin secretion declined, and levels of
HbA rose.)
Effect of Metabolic control on
Complications
• Risk for retinopathy reduced by 37% for
each decrease in HbA of 1 percentage point
(similar to results from DCCT)
Diet and Exercise
• Short-term benefits of diet and exercise well
established; modest reduction in weight (eg, 5-10 lb)
results in dramatic decrease in level of BG, thereby
reducing requirements for medication; however,
high rate of recidivism; results form UKPDS –
patients saw dieticians every 3 to 4 mos for entire
course of study; although patients lost weight
initially, they gained weight ultimately (weight gain
less than in patients undergoing intensive therapy);
HbA rose over time;
Relative Importance
• Increasing activity alone not effective but
important in maintaining weight loss;
weight loss of 5 to 10 lb may lead to
remission in short term; long-term
maintenance of weight loss in population of
overweight individuals difficult to attain;
other interventions required if diet fails.
Hemoglobin A
• Minor fraction of HbA that occurs normally
(glycosylated Hb) and increases in patients
with diabetes; glycosylation of Hb related to
control of diabetes.
Sulfonylureas
• Oldest class of medications for control of diabetes;
HbA decreased by 1 to 2 percentage point; rates of
primary and secondary failure substantial;
mechanism –stimulate secretion of insulin by
binding to specific receptor on B cell; problems –
less effective in nonobese patients; may cause
severe hypoglycemia and weight gain; fail over
time (HbA typically returns to pretreatment level
within 5 yr;
Study – 51 patients with
HbA^7.5%
Randomized to bid insulin or glibenclamide
(glyburide); found that insulin lowered HbA
significantly more than glibenclamide; over
2yr, B-cell function declined more in
patients treated with glibenclaimide than in
those treated with insulin (ie, sulfonylureas
accelerate decline of B-cell function)
Metformin:
Fear of lactic acidosis kept drug off market
in United States until 1995; incidence of
lactic acidosis much lower than with
phenformin; most common oral treatment
for diabetes worldwide; mechanism-inhibits
hepatic glucose output; lowers glucose with
lower levels of insulin (ie, insulin
sensitizer); works in obese and nonobese
patients;
Clinical Trials
1. Found metformin reduces HbA by 1.5 in
patients who had failed diet therapy;
2. When patients who had failed therapy with
sulfonylurea (glyburide) switched to metformin,
no change in HbA, ie, metformin and glyburide
equipotent; when metformin added to glyburide,
HbA fell by =1.7%; to achieve synergistic effect in
combination therapy, drugs must have different
mechanisms of action;
Adverse Effects
• 10% of patients experience gastrointestinal (GI)
discomfort (diarrhea, rumbling or increased
production of gas); lactic acidosis rare, but fatal in
25% to 30% of cases; hypoglycemia does not
occur when metformin used as monothereapy;
titrating dosage may reduce GI effects (speaker
begins with 500 mg once daily, then increases to
500 mg bid, then further increases dose to 850 mg
bid;
Comparison to Sulfonylureas
Similar potencies and long-term efficacies;
adverse-effect profile may determine
choice; because sulfonylureas associated
with hypoglycemia, weight gain, and
possible cardiovascular risk, speaker prefers
metformin as first-line oral therapy; primary
and secondary failure occurs in 3 to 5 yr on
metformin or sulfonylureas.
Ox-glycosidase – Weak Drugs
• Generally used in combination with other
therapies; acarbose reduced HbA by 0.5 to 1.0
percentage point when added to treatment
regiment of diet, sulfonylurea, metformin, or
insulin; mechanism – inhibits absorption of
carbohydrates in small intestine ( increasing
production of methane in large intestine); limiting
intake of carbohydrates and titrating dosage may
reduce adverse effects.
Thiazolidinediones (TZDs)
Increase uptake of glucose in periphery and
suppress release of glucose from liver by binding
to specific nuclear receptors (peroxisome
proliferator-activated receptor-y (PPAR-y);
efficacy –poor as monotherapy (HbA actually rose
in some studies), but good in combination therapy
(leads to additional decrease in HbA of =1%;
Study – compared pioglitazone and rosiglitizone;
no differences in weight gain or effect on HbA,
but pioglitazone had lipis-lowering effect (total
cholesterol, low-density lipoprotein (LDL, and
triglycerides decreased); adverse effects –
generally well tolerated, but edema and
congestive heart failure (CHF) may occur:
although liver dysfunction not commonly
seen, monitoring of liver function still
required (no long-term data available)
Insulin
• Quantity more important than frequency or
mode of delivery; prescribed dosage often
subtherapeutic; no maximum dose;
Studies
• Benefits found for intensive treatment (beginning
with 90 units daily, and increasing to maintain
target level of HbA); single dose of insulin
suspension (NPH) at bedtime (increased every 3
or 4 days until target level of BG reached)
effective at lowering HbA; 85 units required , on
average; other studies show lowest effective dose
60 units, with some patients requiring up to 150
units, on average;
Hypoglycemia
• DCCT showed 3 fold increase in frequency
of hypoglycemic episodes in patients on
intensive therapy, compared to those on
standard therapy; incidence substantially
lower in other studies (maximum of 3
episodes per 100 patient-years)
Monotherapy
• Study compared NPH and insulin glargine;
518 patients followed for 6 mo; differences
in reduction in HbA not statistically
significant; hypoglycemia less severe with
glargine; other studies found no differences
in HbA fasting glucose, or incidence of
severe hypoglycemia.
Combination Therapy
• Most important combination includes diet,
exercise, and medication (patients often
neglect diet once medications started);
metformin good for controlling weight gain;
triple combination therapy (3 oral agents)
does not achieve lower HbA than 70/30
insulin bid plus metformin; insulin therapy
also has positive effects on lipid profile and
costs less than therapy with 3 oral agents.
Conclusions
• Type 2 diabetes difficult to control over time; diet
most cost-effective therapy when effective
behavior modification important to increase
likelihood of success); substantial rate of failure
with oral agents necessitates changing or adding
medications; aggressive use of insulin
recommended; treatment of other risk factors for
cardiovascular disease also critical;
individualization of treatment regimen important.
Diabetes Prevention Program
(DPP)
• Randomized clinical trial; study groups –
a.lifestyle modifications (7% reduction in
weight [=15 lb] plus 30 min of moderateintensity activity [eg, walking] 5 days/wk;
• metformin; troglitazone (discontinued
because of concerns about safety;
• patient selection criteria- impaired glucose
tolerance (IGT)
Life style intervention
• The two major goals of the Diabetes
Prevention Program (DPP) lifestyle
intervention were a minimum of 7% weight
loss/weight maintenance and a minimum of
150 min of physical activity similar in
intensity to brisk walking. Both goals were
hypothesized to be feasible, safe, and
effective based on previous clinical trials in
other countries.
The methods used to achieve these
lifestyle goals include the following
key
features:
• Individual case managers or “lifestyle coaches;
• Frequent contact with participants;
• A structured, state-of-the-art, 16-session core-curriculum that taught
behavioral self-management strategies for weight loss and physical
activity;
• Supervised physical activity sessions;
• A more flexible maintenance intervention, combining group and
individual approaches, motivational campaigns, and “restarts;”
• Individualization through a “toolbox” of adherence strategies;
• Tailoring of materials and strategies to address ethnic diversity; and
finally
• An extensive network of training, feedback, and clinical support.
Goal Based Behavior Intervention
• The DPP lifestyle intervention was designed
to be administered consistently across the
27 centers and 1,079 participants in this arm
of the trial and to allow maximum
flexibility, given the heterogeneity of the
participants.
cont
• There was also a range of education: 25.8% of the
population had13 years of education, 48.1% had
13–16 years, and 26.1% had 17 years. To provide
an intervention that would be appropriate for the
diverse population, a decision was made to use a
goal-based behavioral intervention, where all
participants at all centers were given the same
weight loss and physical activity goal, but
individualization was permitted in the specific
methods used to achieve these goals.
Results
• Weight gain – patients in placebo group
maintained weight; patients on metformin lost
average of 2kg; patients with lifestyle
modifications achieved 7% weight loss initially
and and maintained=5% weight loss over course
of study; development of diabetes – 11% per year
in placebogrouip; 7.8% per year with metformin
therapy; 4.8% per year with lifestyle modification;
over course of therapy, interventions lead to 31%
(with metformin) and 58% (with lifestyle changes)
reduction in development of diabetes; reduction
in risk maintained across age groups.
Wt Loss Goal
• The weight loss goal for all DPP participants was
to lose 7% of initial body weight and to maintain
this weight loss throughout the trial. The decision
to use 7% of initial body weight as the goal was
based on epidemiological data and results of
previous weight loss trials. The risk of developing
diabetes appears to increase with increased levels
of BMI; thus, any decrease in BMI might be
anticipated to decrease risk of diabetes.
Treatment Protocol for Patients
with Type 2 Diabetes
• Heterogeneous disorder; insulin secretion
and resistance vary among patients; begin
treatment with metformin, along with diet
and exercise, then initiating treatment with
insulin if therapeutic goals not reached;
• Strong epidemiologic evidence indicates
that diabetes is associated with lifestyle.
People who migrate to Westernized
countries, with their more sedentary
lifestyles and “Westernized” diets have
greater risk of developing type 2 diabetes
than do their counterparts, who remain in
the native countries (80).
• The preventability of diabetes has been
demonstrated by several randomized trials.
• In a Chinese trial, 577 subjects who had impaired
glucose tolerance (IGT) were randomly assigned to
either the control group or to three different
intervention groups (diet, exercise, or diet plus
exercise) (96). Participants in the diet-intervention
group were prescribed a diet with a specific fat
content and with individual goals for cereal,
vegetables, meat, milk, and oil intake. Compared
with the control group, the diet alone, exercise
alone, and diet-plus exercise interventions were
associated with 31%, 46%, and 42% reductions,
respectively, in risk of developing diabetes.
Smoking
• Several prospective studies have demonstrated that
smoking is associated with a modestly increased risk
of developing diabetes. Although earlier studies did
not detect a significant positive effect, most have not
focused on smoking and diabetes in their major
hypotheses, and the majority have lacked the power to
detect the relatively small but important effect.
Although smoking cessation is associated with a
modest increase in weight, it increases insulin
sensitivity and improves the lipoprotein profile.
Prospective studies clearly demonstrated that the
beneficial effects of smoking cessation on diabetes
risk outweigh the adverse effects on weight gain.
Amount and Types of Fat
• Higher total fat intake has been hypothesized to
contribute to diabetes through two major pathways.
First, a high percentage of fat in the diet may promote
weight gain and the development of obesity. Second,
a high percentage of fat in the diet may cause insulin
resistance, independent of obesity. The first
hypothesis has been hotly debated within recent years
(53, 148). Although in short-term studies, a modest
reduction in body weight has been seen typically in
individuals assigned to diets with a lower percentage
of calories from fat, recently published weight loss
continued
trials on low-carbohydrate-high-fat/protein
diets suggest greater weight loss with high-fat
diets than with low-fat diets (30, 112).
Quality and Quantity of
Carbohydrates
• Low-fat, high-carbohydrate diets generally
produce high postprandial glucose and
insulin responses. However, similar to total
fat, the total percentage of energy derived
from carbohydrates in the diet generally has
not been found to predict diabetes risk.
Diets low in carbohydrates –
epidemiology of obesity parallels
consumption of fat, not carbohydrates;
short-term data suggests diets high in fat
and low in carbohydrates better for weight
loss than diets high in carbohydrates and
low in fat; however, no difference between
groups at 1 yr;
Micronutrients
• Magnesium is an important component of
whole grains and other unprocessed foods,
such as nuts and green leafy vegetables. Its
intake has substantially decreased in
industrialized countries owing to
overprocessing of foods and adoption of
western diets. Hypomagnesemia is a
frequent condition in patients with type 2
diabetes (129).
Coffee
• An inverse association between coffee
consumption and the risk of type 2 diabetes has
been observed in several prospective cohort
studies (106, 108, 131, 134), but not in all (113).
The beneficial effect of long-term coffee
consumption on the development of diabetes has
been attributed to caffeine, but other constituents
of coffee, e.g., potassium, niacin, magnesium and
antioxidant substances, may have beneficial
effects on glucose metabolism and insulin
resistance as well.
Meat
• Frequent consumption of meat, in particular
processed meat, has been consistently
shown to increase the risk of diabetes in
prospective studies (34, 116, 119, 136).
Study Design
• Impaired glucose tolerance was defined as a
plasma glucose concentration of 140 to 200
mg per deciliter (7.8 to 11.0 mmol per liter)
two hours after the oral administration of 75
g of glucose in subjects whose plasma
glucose concentration after an overnight fast
was less than 140 mg per deciliter.
Assessment of End Point
• Diabetes was defined according to the 1985
criteria of the World Health Organization as
either a fasting plasma glucose
concentration of 140 mg per deciliter or
higher or a plasma glucose concentration of
200 mg per deciliter or higher two hours
after an oral glucose challenge.
Session 1. Welcome to the Lifestyle
Balance Program
• Build commitment to the DPP lifestyle change
program by recording personal reasons for joining
the DPP and perceived benefits to self, family, and
others. Highlight the two study goals: 7% weight
loss and 150 minutes of weekly physical activity
and review key aspects of the relationship between
the lifestyle coach and participant in working
towards these goals. Introduce self-monitoring of
food intake.
Session 2. Be a Fat Detective
• Introduce regular self-monitoring of weight
at home. Help participants find the main
sources of fat in their diet through selfmonitoring fat grams using the “DPP Fat
Counter” and by reading food labels. Assign
a fat gram goal based on starting weight.
Session 3. Three Ways to Eat Less
Fat
• Practice self-monitoring skills, including
weighing and measuring foods and
estimating portion size of foods. Teach three
ways to eat less fat: eat high-fat foods less
often, eat smaller portions, and substitute
lower fat foods and cooking methods.
Session 4. Healthy Eating
• Emphasize the importance of a regular meal
pattern and eating slowly. Use the Food
Guide Pyramid (USDA) as a model for
healthy eating and compare personal eating
patterns to these recommendations.
Recommend specific low-fat, low-calorie
substitutes
Session 5. Move Those Muscles
• Introduce physical activity and begin to
build to 150 minutes of physical activity
over the next 4 weeks, using activities such
as brisk walking. Begin self-monitoring of
physical activity as well as food intake.
Review personal activity history and likes
and dislikes about physical activity.
Encourage attendance at group supervised
activity sessions.
Session 6. Being Active: A Way of
Life
• Help participants learn to find the time to be
physically active each day by including short
bouts (10–15 min) and healthy lifestyle activities,
e.g., climbing stairs and walking extra blocks from
the bus stop. Teach the basic principles for
exercising safely, what to do in the event of injury,
and knowing when to stop.
Session 7. Tip the Calorie Balance
• Teach the fundamental principle of energy
balance and what it takes to lose 1–2 lbs per
week. For those individuals who have made
little progress with weight loss, assign selfmonitoring of calories as well as fat grams
or provide a structured meal plan at reduced
calorie levels.
Session 8. Take Charge of What’s
Around You
• Introduce the principle of stimulus control.
Identify cues in the participant’s home
environment that lead to unhealthy food and
activity choices and discuss ways to change
them.
Session 9: Problem Solving
• Present the five-step model of problem
solving: describe the problem as links in a
behavior chain, brainstorm possible
solutions, pick one solution to try, make a
positive action plan, evaluate the success of
the solution. Apply the problem-solving
model to eating and exercise problems.
Session 10. The Four Keys to
Healthy Eating Out
• Introduce four basic skills for managing
eating away from home: anticipating and
planning ahead, positive assertion, stimulus
control, and making healthy food choices.
Session 11. Talk Back to Negative
Thoughts
• Practice identifying common patterns of
self-defeating, negative thoughts and learn
to counter these thoughts with positive
statements.
Session 12. The Slippery Slope of
Lifestyle Change
• Stress that slips are normal and learning to
recover quickly is the key to success. Teach
participants to recognize personal triggers
for slips, their reactions to those slips, and
what it takes to get back on track.
Session 13. Jump Start Your Activity
Plan
• Introduce the basic principles of aerobic
fitness: frequency, intensity, time, type of
activity (FITT). Teach participants to
measure their heart rate and perceived level
of exertion as a way of determining the
appropriate levels of activity. Discuss ways
to cope with boredom by adding variety to
the physical activity plan.
Session 14. Make Social Cues Work
for You
• Present strategies for managing problem social
cues, e.g., being pressured to overeat, and help
participants learn to use social cues to promote
healthy behaviors, e.g., making regular dates with
a walking partner or group. Review specific
strategies for coping with social events such as
parties, vacations, and holidays.
Session 15. You Can Manage Stress
• Highlight the importance of coping with
stress, including stress caused by the DPP,
by using all of the skills previously taught,
e.g., positive assertion, engaging social
support, problem solving, planning, talking
back to negative thoughts, and being
physically active.
Session 16. Ways to Stay Motivated
• Enhance motivation to maintain behavior
change by reviewing participants’ personal
reasons for joining DPP and by recognizing
personal successes thus far. Introduce other
strategies for staying motivated including
posting signs of progress, setting new goals,
creating friendly competition, and seeking
social support from DPP staff and others.
Self-monitoring
• They used a pocket sized “Keeping Track”
booklet, developed for the DPP that had spaces for
recording 7 days of food intake with fat and
calorie values, as well as physical activity.
Participants were also given “The DPP Lifestyle
Balance Fat Counter” booklet, which indicated the
fat and calorie content for 1,500 alphabetized food
names, including regional/ethnic foods suggested
by DPP sites for their local population