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- Title
- United Kingdom Prospective Diabetes
Study 24: a 6-year, randomized,
controlled trial comparing sulfonylurea,
insulin, and metformin therapy in
patients with newly diagnosed type 2
diabetes that could not be controlled
with diet therapy. United Kingdom
Prospective Diabetes Study Group [see
comments]
- Address
-
- Source
- Ann Intern Med, 1998 Feb, 128:3,
165-75
- Abstract
- BACKGROUND: Uncertainty exists about
the suitability of oral hypoglycemic
drugs and insulin therapy for patients
with newly diagnosed type 2 diabetes.
OBJECTIVE: To assess and compare
response to sulfonylurea, insulin, or
metformin over 6 years in patients with
newly diagnosed type 2 diabetes in whom
disease could and could not be
controlled with diet therapy alone.
DESIGN: Multicenter, randomized,
controlled trial. SETTING: Outpatient
diabetes clinics of 15 hospitals in the
United Kingdom. INTERVENTION:
Sulfonylurea (chlorpropamide or
glyburide), insulin, or metformin (if
patients were obese). PATIENTS: 458
patients with newly diagnosed type 2
diabetes that could not be controlled
with diet and had hyperglycemic symptoms
or fasting plasma glucose levels greater
than 15 mmol/L during the initial 3
months of diet therapy (primary diet
failure group) and 1620 patients in whom
disease was controlled by diet therapy
and who had fasting plasma glucose
levels of 6 to 15 mmol/L and no
hyperglycemic symptoms while receiving
diet therapy alone. MEASUREMENTS:
Fasting plasma levels of glucose and
insulin, hemoglobin A1c concentrations,
body weight, and therapy required.
RESULTS: Compared with the
diet-controlled group, the primary diet
failure group was younger and less obese
and had more retinopathy, lower fasting
plasma insulin levels, and reduced
beta-cell function. At 6 years, patients
allocated to insulin had lower fasting
plasma glucose levels than did patients
allocated to oral agents, but hemoglobin
A1c concentrations were similar.
Forty-eight percent (95% CI, 37% to 58%)
of patients in the primary diet failure
group maintained hemoglobin A1c
concentrations less than 0.08. By 6
years, 51% of patients (CI, 42% to 62%)
allocated to ultralente insulin required
additional short-acting insulin and 66%
of patients (CI, 58% to 73%) allocated
to sulfonylurea required additional
therapy with metformin or insulin to
control symptoms and maintain fasting
plasma glucose levels less than 15 mmol/L.
Patients allocated to insulin gained
more weight and had more hypoglycemic
attacks than did patients allocated to
sulfonylurea. Obese patients allocated
to metformin gained the least weight and
had the fewest hypoglycemic attacks. For
all therapies, control achieved at 6
years was worse in the primary diet
failure group than in the
diet-controlled group. CONCLUSIONS:
Because initial insulin therapy induced
more hypoglycemic reactions and weight
gain without necessarily providing
better control, it may be reasonable to
start with oral agents and change to
insulin if goals for glycemic levels are
not achieved.
- Language of Publication
- English
- Unique Identifier
- 98108431
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- MeSH Heading (Major)
- Diabetes Mellitus, Non-Insulin-Dependent|BL/CO/DH/*DT;
Hypoglycemic Agents|*TU; Insulin|*TU;
Metformin|*TU; Sulfonylurea Compounds|*TU
- MeSH Heading
- Adult; Aged; Blood Glucose|ME;
Combined Modality Therapy; Comparative
Study; Female; Follow-Up Studies; Great
Britain; Hemoglobin A, Glycosylated|ME;
Human; Hypoglycemia|ET; Male; Middle
Age; Obesity|BL/CO; Prospective Studies;
Statistics; Support, Non-U.S. Gov't;
Support, U.S. Gov't, P.H.S.
- Publication Type
- CLINICAL TRIAL; JOURNAL ARTICLE;
MULTICENTER STUDY; RANDOMIZED CONTROLLED
TRIAL
- ISSN
- 0003-4819
- Country of Publication
- UNITED STATES
Record 2 from database: MEDLINE
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- Title
- Comparison of a high-carbohydrate diet
with a high-monounsaturated-fat diet in
patients with non-insulin-dependent
diabetes mellitus.
- Author
- Garg A; Bonanome A; Grundy SM; Zhang
ZJ; Unger RH
- Address
- Center for Human Nutrition, University
of Texas Southwestern Medical Center,
Dallas 75235-9052.
- Source
- N Engl J Med, 1988 Sep, 319:13, 829-34
- Abstract
- We compared a high-carbohydrate diet
with a high-fat diet (specifically, a
diet high in monounsaturated fatty
acids) for effects on glycemic control
and plasma lipoproteins in 10 patients
with non-insulin-dependent diabetes
mellitus (NIDDM) receiving insulin
therapy. The patients were randomly
assigned to receive first one diet and
then the other, each for 28 days, in a
metabolic ward. In the high-carbohydrate
diet, 25 percent of the energy was in
the form of fat and 60 percent in the
form of carbohydrates (47 percent of the
total energy was in the form of complex
carbohydrates); the
high-monounsaturated-fat diet was 50
percent fat (33 percent of the total
energy in the form of monounsaturated
fatty acids) and 35 percent
carbohydrates. The two diets had the
same amounts of simple carbohydrates and
fiber. As compared with the
high-carbohydrate diet, the
high-monounsaturated-fat diet resulted
in lower mean plasma glucose levels and
reduced insulin requirements, lower
levels of plasma triglycerides and
very-low-density lipoprotein cholesterol
(lower by 25 and 35 percent,
respectively; P less than 0.01), and
higher levels of high-density
lipoprotein (HDL) cholesterol (higher by
13 percent; P less than 0.005). Levels
of total cholesterol and low-density
lipoprotein (LDL) cholesterol did not
differ significantly in patients on the
two diets. These preliminary results
suggest that partial replacement of
complex carbohydrates with
monounsaturated fatty acids in the diets
of patients with NIDDM does not increase
the level of LDL cholesterol and may
improve glycemic control and the levels
of plasma triglycerides and HDL
cholesterol.
- Language of Publication
- English
- Unique Identifier
- 88318869
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- MeSH Heading (Major)
- Diabetes Mellitus,
Non-Insulin-Dependent|*DH; Dietary
Carbohydrates|*AD; Dietary Fats|*AD;
Fatty Acids, Monounsaturated|*AD
- MeSH Heading
- Adult; Aged; Blood Glucose|AN;
Cholesterol|BL; Comparative Study;
Energy Intake; Human; Insulin|AD;
Lipoproteins, LDL Cholesterol|BL;
Lipoproteins, VLDL|BL; Middle Age;
Random Allocation; Support, Non-U.S.
Gov't; Support, U.S. Gov't, Non-P.H.S.;
Support, U.S. Gov't, P.H.S.;
Triglycerides|BL
- Publication Type
- CLINICAL TRIAL; JOURNAL ARTICLE;
RANDOMIZED CONTROLLED TRIAL
- ISSN
- 0028-4793
- Country of Publication
- UNITED STATES
Record 3 from database: MEDLINE
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- Title
- Diet only or diet and sulfonylureas in
mild type II diabetes (NIDDM)?
Pathophysiologic and therapeutic
implications.
- Author
- Sinay IR; Arias P; Schnitman MA;
Damilano SA; Faingold MC; Moguilevsky JA
- Address
- Servicio de Endocrinologia, Hospital
FrancÆes, Buenos Aires, Argentina.
- Source
- Acta Diabetol Lat, 1988 Oct, 25:4,
289-97
- Abstract
- Plasma glucose, insulin and C-peptide
responses to a test meal were studied in
7 nonobese patients with type II
diabetes mellitus (NIDDM) treated with
diet alone and after 6 months of
gliclazide therapy, as well as in 6
matched controls. The glycemic levels
were significantly higher (p less than
0.05) in patients under diet alone than
in controls and after gliclazide
treatment (peak: 12.8 +/- 1.0; 7.9 +/-
0.4 and 10.0 +/- 0.5 mmol/l,
respectively; means +/- SEM). Diet and
gliclazide treated patients showed a
reduced B-cell response during the first
hour after the meal as indicated by
insulin and C-peptide values and areas
(insulin areas 0-60 min: controls 57.9
+/- 10.9; p less than 0.01 vs diet alone
14.2 +/- 2.7 and vs gliclazide 22.1 +/-
2.8 microU/ml/min). The hypoinsulinemic
phase lasted from 20 to 60 min before
gliclazide, and from 20 to 45 min after
gliclazide. The first significant
C-peptide increase, detected at 10 min
in controls and at 30 min under diet
alone, was advanced to 15 min after
gliclazide treatment. In conclusion:
patients with mild, diet-treated NIDDM
show a sluggish and attenuated B-cell
response to a physiologic challenge
(test meal); this secretory impairment
is present even after a complete post-prandial
glycemic normalization, supporting the
idea of a persistent defect.
Nevertheless, the slight improvement
observed in insulin secretion after
gliclazide treatment may be promoting,
at least partially, the normalization of
prandial hyperglycemia. The benefits of
this normalization in diabetic patients
previously controlled by diet only await
further investigation.
- Language of Publication
- English
- Unique Identifier
- 89224955
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- MeSH Heading (Major)
- Diabetes Mellitus, Non-Insulin-Dependent|BL/*DT/UR;
Diabetic Diet|*; Hypoglycemic Agents|*TU
- MeSH Heading
- Aged; Blood Glucose|AN; C-Peptide|BL/UR;
Combined Modality Therapy; Comparative
Study; Female; Hemoglobin A,
Glycosylated|AN; Human; Hypoglycemia|ET;
Insulin|BL; Male; Middle Age; Reference
Values
- Publication Type
- JOURNAL ARTICLE
- ISSN
- 0001-5563
- Country of Publication
- ITALY
Record 4 from database: MEDLINE
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- Title
- UK Prospective Diabetes Study (UKPDS).
IX: Relationships of urinary albumin and
N-acetylglucosaminidase to glycaemia and
hypertension at diagnosis of type 2
(non-insulin-dependent) diabetes
mellitus and after 3 months diet
therapy.
- Address
-
- Source
- Diabetologia, 1993 Sep, 36:9, 835-42
- Abstract
- In 672 newly-diagnosed, Type 2
(non-insulin-dependent) diabetic
patients without urinary infection, aged
51 (9) years, mean (1 SD), 28% of
patients had raised albuminuria, defined
as albumin excretion greater than 25
mg/l and 66% raised urinary N-acetylglucosaminidase
excretion defined as greater than 300
mumol.h-1.l-1 (both urinary analytes
corrected by linear regression on
urinary creatinine to 10 mmol/1). In a
univariate analysis, urinary N-acetylglucosaminidase
and albumin excretion correlated with
each other (rs = 0.42, p < 0.001),
and with fasting plasma glucose (rs =
0.46 and rs = 0.27, p < 0.001,
respectively). The association of
urinary albumin and N-acetylglucosaminidase
remained significant after taking the
fasting plasma glucose levels into
account, partial rs = 0.34, p <
0.001. After 3 months of dietary therapy
BMI decreased from 29.7 (5.9) kg/m2 to
28.8 (5.8) kg/m2, fasting plasma glucose
levels from 12.2 (3.8) mmol/l to 9.8
(3.8) mmol/l, and systolic blood
pressure from 143 (21.8) mmHg to 131
(20.3) mmHg, p < 0.001 for each
variable. There were concomitant
decreases in urinary N-acetylglucosaminidase,
geometric mean (1 SD interval), 397
mumol.h-1.l-1 (216 to 728) to 291
mumol.h-1.l-1 (160 to 528), p < 0.001
and in albumin excretion 16 mg/l (5 to
51) to 13 mg/l (4 to 40), p < 0.001.
The decrease in urinary N-acetylglucosaminidase,
but not the decrease in urinary albumin
excretion, was associated with the
initial degree of glycaemia and the
decrease in glycaemia in response to
diet.(ABSTRACT TRUNCATED AT 250 WORDS)
- Language of Publication
- English
- Unique Identifier
- 94010013
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- MeSH Heading (Major)
- Acetylglucosaminidase|BL/*UR;
Albuminuria|*; Blood Glucose|*ME;
Diabetes Mellitus,
Non-Insulin-Dependent|*CO/DH/*PP;
Diabetic Diet|*; Hypertension|CO/*PP
- MeSH Heading
- Biological Markers|BL/UR; Blood
Pressure; Female; Great Britain;
Hemoglobin A, Glycosylated|AN; Human;
Male; Middle Age; Prospective Studies;
Regression Analysis; Support, Non-U.S.
Gov't; Support, U.S. Gov't, P.H.S.; Time
Factors
- Publication Type
- JOURNAL ARTICLE; MULTICENTER STUDY
- ISSN
- 0012-186X
- Country of Publication
- GERMANY
Record 5 from database: MEDLINE
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- Title
- Effects of diet composition and
ketosis on glycemia during
very-low-energy-diet therapy in obese
patients with non-insulin-dependent
diabetes mellitus.
- Author
- Gumbiner B; Wendel JA; McDermott MP
- Address
- Department of Medicine, Monroe
Community Hospital, Rochester, NY 14620,
USA.
- Source
- Am J Clin Nutr, 1996 Jan, 63:1, 110-5
- Abstract
- To determine whether high-ketogenic
very-low-energy diets (VLEDs) can reduce
hepatic glucose output (HGO) and
hyperglycemia more effectively than can
low-ketogenic VLEDs in obese patients
with non-insulin-dependent diabetes
mellitus (NIDDM), seven patients were
treated with a high-ketogenic VLED for 3
wk and were compared with six patients
treated with a low-ketogenic VLED. All
patients were then crossed over and
treated with the alternate diet for
another 3 wk. Basal HGO, fasting ketone
bodies, and glycemia, insulin, and
C-peptide after fasting and an
oral-glucose-tolerance test (OGTT) were
measured. Before treatment, prediet
weight and fasting, OGTT, and HGO
measurements were not different between
groups. After dieting, weight loss was
not different between the groups.
However, fasting and OGTT glycemia were
lower during treatment with the high-ketogenic
VLED than with the low-ketogenic VLED
(treatment effect: P < 0.05, by
analysis of variance). Moreover, there
was a strong correlation between basal
HGO and fasting plasma ketone bodies (r
= -0.71 at 3 wk, r = -0.67 at 6 wk; both
P < 0.05). In contrast, fasting and
OGTT plasma insulin and C-peptide
concentrations were not different
between treatment groups. These data
indicate that in obese patients with
NIDDM, high-ketogenic VLEDs have a more
clinically favorable effect on glycemia
than do low-ketogenic VLEDs.
- Language of Publication
- English
- Unique Identifier
- 96112784
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- MeSH Heading (Major)
- Blood Glucose|*ME; Diabetes Mellitus,
Non-Insulin-Dependent|BL/*CO; Diet,
Reducing|*; Ketosis|*CO; Obesity|BL/CO/*DH
- MeSH Heading
- C-Peptide|BL; Comparative Study;
Cross-Over Studies; Energy Metabolism;
Female; Glucose|ME; Glucose Tolerance
Test; Human; Insulin|BL; Ketone
Bodies|BL; Liver|ME; Male; Middle Age;
Support, Non-U.S. Gov't; Support, U.S.
Gov't, P.H.S.
- Publication Type
- CLINICAL TRIAL; CONTROLLED CLINICAL
TRIAL; JOURNAL ARTICLE
- ISSN
- 0002-9165
- Country of Publication
- UNITED STATES
Record 6 from database: MEDLINE
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- Title
- Body fat distribution and
non-insulin-dependent diabetes:
comparison of a fiber-rich,
high-carbohydrate, low-fat (23%) diet
and a 35% fat diet high in
monounsaturated fat [see comments]
- Author
- Walker KZ; ODea K; Johnson L; Sinclair
AJ; Piers LS; Nicholson GC; Muir JG
- Address
- School of Nutrition and Public Health,
Deakin University, Victoria, Australia.
- Source
- Am J Clin Nutr, 1996 Feb, 63:2, 254-60
- Abstract
- The effects of a fiber-rich,
high-carbohydrate, low-fat (HCLF) diet
and a modified-fat (MF) diet high in
monounsaturated fat on body fat
distribution were examined by
dual-energy X-ray absorptiometry (DXA)
in 16 subjects with
non-insulin-dependent diabetes (NIDDM)
during a randomized crossover study.
Subjects lost similar amounts of body
fat consuming the HCLF and MF diets
(-0.83 +/- 0.37 and -0.87 +/- 0.40 kg,
respectively) despite a marked
difference in total fat consumption.
With the MF diet, the ratio of upper- to
lower-body fat (UF:LF) remained
unchanged because fat was lost
proportionately from the upper and lower
body. In contrast, with the HCLF diet, a
disproportionate loss of lower-body fat
caused the UF:LF to increase. The
effects of diet on regional body fat
loss were significant (P < 0.05,
two-factor repeated-measures ANOVA).
- Language of Publication
- English
- Unique Identifier
- 96148840
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- MeSH Heading (Major)
- Adipose Tissue|*AH/ME; Diabetes
Mellitus, Non-Insulin-Dependent|BL/*DH/ME;
Dietary Carbohydrates|*AD; Dietary Fats,
Unsaturated|*AD; Dietary Fiber|*AD
- MeSH Heading
- Anthropometry; Body Composition; Body
Mass Index; Body Weight; Comparative
Study; Cross-Over Studies; Densitometry,
X-Ray; Fatty Acids|BL; Female; Human;
Male; Middle Age; Patient Compliance;
Support, Non-U.S. Gov't
- Publication Type
- CLINICAL TRIAL; JOURNAL ARTICLE;
RANDOMIZED CONTROLLED TRIAL
- ISSN
- 0002-9165
- Country of Publication
- UNITED STATES
Record 7 from database: MEDLINE
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- Title
- Randomized trial of diet versus diet
plus cardiovascular conditioning on
glucose levels in gestational diabetes.
- Author
- Jovanovic Peterson L; Durak EP;
Peterson CM
- Address
- Sansum Medical Research Foundation,
Santa Barbara, CA 93105.
- Source
- Am J Obstet Gynecol, 1989 Aug, 161:2,
415-9
- Abstract
- We studied the impact of a training
program on glucose tolerance in
gestational diabetes mellitus. Women
with gestational diabetes mellitus (N =
19) were randomized into either group I,
a 6-week diet alone group (24 to 30
kcal/kg/24 hours; 20% protein, 40%
carbohydrate, 40% fat), or group II,
which followed the same diet plus
exercise (20 minutes three times a week
for 6 weeks). An arm ergometer was used
to maintain heart rate in the training
range. Glycemic response was monitored
by glycosylated hemoglobin, a 50 gm oral
glucose challenge with a fasting and
1-hour plasma glucose, and blood glucose
self-monitoring, fasting and 1 hour
after meals. Week 1 glycemic parameters
were the same for both groups. Week 6
data (mean +/- SD) were as follows:
group I glycosylated hemoglobin, 4.7% +
0.2% versus group II, 4.2% +/- 0.2%; p
less
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