-
International Journal of Obesity (2005) Jun 2012Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.
DESIGN
A randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers.
SUBJECTS
A total of 564 adults (n=90-98 per group; body mass index 30-40 kg m(-2)) enrolled, 398 entered the extension and 268 completed the 2-year trial. Participants received diet (500 kcal deficit per day) and exercise counseling during 2-week run-in, before being randomly assigned (with a telephone or web-based system) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg, n=90-95), placebo (n=98) or open-label orlistat (120 mg × 3, n=95). After 1 year, liraglutide/placebo recipients switched to liraglutide 2.4 mg, then 3.0 mg (based on 20-week and 1-year results, respectively). The trial ran from January 2007-April 2009 and is registered with Clinicaltrials.gov, number NCT00480909.
RESULTS
From randomization to year 1, liraglutide 3.0 mg recipients lost 5.8 kg (95% confidence interval 3.7-8.0) more weight than those on placebo and 3.8 kg (1.6-6.0) more than those on orlistat (P0.0001; intention-to-treat, last-observation-carried-forward). At year 2, participants on liraglutide 2.4/3.0 mg for the full 2 years (pooled group, n=184) lost 3.0 kg (1.3-4.7) more weight than those on orlistat (n=95; P<0.001). Completers on liraglutide 2.4/3.0 mg (n=92) maintained a 2-year weight loss of 7.8 kg from screening. With liraglutide 3.0 mg, 20-week body fat decreased by 15.4% and lean tissue by 2.0%. The most frequent drug-related side effects were mild to moderate, transient nausea and vomiting. With liraglutide 2.4/3.0 mg, the 2-year prevalence of prediabetes and metabolic syndrome decreased by 52 and 59%, with improvements in blood pressure and lipids.
CONCLUSION
Liraglutide is well tolerated, sustains weight loss over 2 years and improves cardiovascular risk factors.
Topics: Adolescent; Adult; Aged; Analysis of Variance; Anti-Obesity Agents; Double-Blind Method; Drug Administration Schedule; Europe; Exercise Therapy; Female; Glucagon-Like Peptide 1; Humans; Liraglutide; Male; Middle Aged; Obesity; Prediabetic State; Risk Reduction Behavior; Treatment Outcome; Weight Loss; Young Adult
PubMed: 21844879
DOI: 10.1038/ijo.2011.158 -
The Medical Letter on Drugs and... Nov 2016
Review
Topics: Clinical Trials as Topic; Humans; Hypoglycemic Agents; Metformin; Prediabetic State
PubMed: 27805573
DOI: No ID Found -
Current Diabetes Reports Sep 2018Using a global perspective, this review collates evidence on the heterogeneity of prediabetes definitions and diagnostic methods, their clinical and public health... (Review)
Review
PURPOSE OF REVIEW
Using a global perspective, this review collates evidence on the heterogeneity of prediabetes definitions and diagnostic methods, their clinical and public health implications, and discusses possible options for improvement.
RECENT FINDINGS
Our review notes that the concept of prediabetes is increasingly recognized worldwide, but against a background of non-uniform definition and diagnostic criteria. This results in widely varying burden estimation. Current evidence shows a variety of prediabetes phenotypes. This reflects biological and diagnostic heterogeneity, resulting from the use of different tests (glucose or HbA) and thresholds to define prediabetes. The biological and diagnostic variabilities have implications for the characterization of the burden of prediabetes, natural history, prognosis, screening, implementation of lifestyle or drug interventions to mitigate related health risks, and monitoring of the effects of such interventions.
Topics: Biomarkers; Cost of Illness; Humans; Hyperglycemia; Internationality; Phenotype; Prediabetic State
PubMed: 30229351
DOI: 10.1007/s11892-018-1089-y -
JAMA Internal Medicine Apr 2021
Topics: Blood Glucose; Humans; Prediabetic State; Risk Factors
PubMed: 33555307
DOI: 10.1001/jamainternmed.2020.8773 -
Diabetes/metabolism Research and Reviews Sep 2015Diabetes mellitus (DM) and metabolic syndrome are important targets for secondary prevention in cardiovascular disease. However, the prevalence in patients undergoing...
BACKGROUND
Diabetes mellitus (DM) and metabolic syndrome are important targets for secondary prevention in cardiovascular disease. However, the prevalence in patients undergoing elective percutaneous coronary intervention is not well defined. We aimed to analyse the prevalence and characteristics of patients undergoing percutaneous coronary intervention with previously unrecognized prediabetes, diabetes and metabolic syndrome.
METHODS
Data were collected from 740 patients undergoing elective percutaneous coronary intervention between November 2010 and March 2013 at a tertiary referral center. Prevalence of DM and prediabetes was evaluated using Haemoglobin A1c (A1c ≥ 6.5% for DM, A1c 5.7-6.4% for prediabetes). A modified definition was used for metabolic syndrome [three or more of the following criteria: body mass index ≥30 kg/m2; triglycerides ≥ 150 mg/dL; high density lipoprotein <40 mg/dL in men and <50 mg/dL in women; systolic blood pressure ≥ 130 mmHg and/or diastolic ≥ 85 mmHg; and A1c ≥ 5.7% or on therapy].
RESULTS
Mean age was 67 years, median body mass index was 28.2 kg/m(2) and 39% had known DM. Of those without known DM, 8.3% and 58.5% met A1c criteria for DM and for prediabetes at time of percutaneous coronary intervention. Overall, 54.9% met criteria for metabolic syndrome (69.2% of patients with DM and 45.8% of patients without DM).
CONCLUSION
Among patients undergoing elective percutaneous coronary intervention, a substantial number were identified with a new DM, prediabetes, and/or metabolic syndrome. Routine screening for an abnormal glucometabolic state at the time of revascularization may be useful for identifying patients who may benefit from additional targeting of modifiable risk factors.
Topics: Aged; Cohort Studies; Coronary Occlusion; Delayed Diagnosis; Diabetes Mellitus; Diabetic Angiopathies; Diabetic Cardiomyopathies; Elective Surgical Procedures; Female; Glycated Hemoglobin; Humans; Male; Metabolic Syndrome; Middle Aged; New York City; Percutaneous Coronary Intervention; Prediabetic State; Prevalence; Risk Factors; Tertiary Care Centers
PubMed: 25728823
DOI: 10.1002/dmrr.2646 -
Expert Opinion on Pharmacotherapy Oct 2018Prediabetes is a state wherein blood glucose levels are above normal but below the diagnostic threshold for diabetes. Seventy percent of patients with prediabetes... (Review)
Review
INTRODUCTION
Prediabetes is a state wherein blood glucose levels are above normal but below the diagnostic threshold for diabetes. Seventy percent of patients with prediabetes develop type 2 diabetes in their lifetime. Despite this, prediabetes frequently goes undiagnosed.
AREAS COVERED
This review focuses on the pharmacological treatment of prediabetes and the prevention of progression to diabetes. A literature search was carried out on PubMed and Embase to review randomized controlled trials examining treatment of prediabetes. Emerging pharmacological therapies with potential benefit are discussed.
EXPERT OPINION
Lifestyle intervention is the cornerstone for preventing progression to diabetes, but metformin remains the first line pharmacological intervention. There appears to be minimal additive effect of combining metformin with lifestyle changes. It would be interesting to assess whether using combination pharmacological approaches plus or minus lifestyle interventions have any additive benefit. Despite the good level of evidence available, the penetrance of any interventions remains very low in part due to the prodromal categorization of the prediabetic state.
Topics: Drug Therapy; Humans; Hypoglycemic Agents; Prediabetic State
PubMed: 30198813
DOI: 10.1080/14656566.2018.1517155 -
Journal of the Indian Medical... Nov 2005Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) are forerunners of type 2 diabetes mellitus (DM) and are now recognised as prediabetes states.... (Review)
Review
Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) are forerunners of type 2 diabetes mellitus (DM) and are now recognised as prediabetes states. Cardiovascular disease (CVD) is associated with these conditions and there are many studies such as the Da Quin IGT and DM study; Finnish Diabetes Prevention Study(DPS); The Diabetes Prevention Program(DPP) which have clearly shown the efficacy and supremacy of diet intervention in controlling progression of the prediabetes state to type 2 DM. Weight reduction, increasing physical activity and restricting not only total calories but also deriving them from more healthy sources by reducing the total intake of fat, changing n-6 PUFA to n-3 PUFA, increasing the intake of fibre rich carbohydrates and the use of antioxidants have not only long-term health benefits but also can be a very useful cost-effective tool to overcome the burden of type 2 DM in our country. Prevention of type 2 DM is not a dream but a reality and this can be achieved from a path through our kitchen. Faulty nutrition seems to be the main culprit in this wide-spread epidemic of diabetes and nutritional therapy in prediabetes state appears to be the only option in our hands.
Topics: Diabetes Mellitus, Type 2; Disease Progression; Fatty Acids, Omega-3; Fatty Acids, Omega-6; Glucose Intolerance; Health Behavior; Humans; Metabolic Syndrome; Nutritional Status; Prediabetic State; Self Care
PubMed: 16570763
DOI: No ID Found -
Nutrients Jul 2022It is controversial whether lifestyle-induced weight loss (LIWL) intervention provides long-term benefit. Here, we investigated whether the degree of weight loss (WL) in...
It is controversial whether lifestyle-induced weight loss (LIWL) intervention provides long-term benefit. Here, we investigated whether the degree of weight loss (WL) in a controlled LIWL intervention study determined the risk of prediabetes and recurrence of metabolic syndrome (MetS) during a 5-year follow-up. Following LIWL, 58 male participants (age 45−55 years) were divided into four quartiles based on initial WL: Q1 (WL 0−8.1%, n = 15), Q2 (WL 8.1−12.8%, n = 14), Q3 (WL 12.8−16.0%, n = 14), and Q4 (WL 16.0−27.5%, n = 15). We analyzed changes in BMI, HDL cholesterol, triglycerides (TGs), blood pressure, and fasting plasma glucose (FPG) at annual follow-up visits. With a weight gain after LIWL between 1.2 (Q2) and 2.5 kg/year (Q4), the reduction in BMI was maintained for 4 (Q2, p = 0.03) or 5 (Q3, p = 0.03; Q4, p < 0.01) years, respectively, and an increase in FPG levels above baseline values was prevented in Q2−Q4. Accordingly, there was no increase in prediabetes incidence after LIWL in participants in Q2 (up to 2 years), Q3 and Q4 (up to 5 years). A sustained reduction in MetS was maintained in Q4 during the 5-year follow-up. The present data indicate that a greater initial LIWL reduces the risk of prediabetes and recurrence of MetS for up to 5 years.
Topics: Follow-Up Studies; Humans; Life Style; Male; Metabolic Syndrome; Middle Aged; Prediabetic State; Weight Loss
PubMed: 35893913
DOI: 10.3390/nu14153060 -
Scientific Reports Feb 2024We aimed to examine the concordance of type-2 diabetes, prediabetes and the metabolic syndrome in couples. In cross-sectional analyses, we used data from 1173 couples...
We aimed to examine the concordance of type-2 diabetes, prediabetes and the metabolic syndrome in couples. In cross-sectional analyses, we used data from 1173 couples with index persons from the Heinz Nixdorf Recall Study (2011-2015), a population-based cohort study in Western Germany, and partners from the associated Heinz Nixdorf Multigeneration Study (2013-2016). Mean age (standard deviation) was 67.2 (6.6) years in index persons, and 67.8 (7.7) years in partners. The exposure was the presence of diabetes, prediabetes or metabolic syndrome in index persons, the outcome was the presence of the same health status in partners. Diabetes was defined by either self-reported diagnosis, intake of antidiabetic drugs or insulin, or HbA1c ≥ 6.5%. If the index person had prediabetes or diabetes, the partner was 1.46 (95% CI 1.07-2.00) times more likely to have diabetes than partners of index persons without the condition in the crude model (adjusted model: 1.33 (0.97-1.83)). For self-reported diabetes and for the metabolic syndrome, the corresponding prevalence ratios were 1.33 (0.90-1.97) and 1.17 (1.03-1.32), respectively (adjusted models: 1.23 (0.77-1.94), 1.04 (0.91-1.18)). In German couples, there was weak to moderate concordance of type-2 diabetes, prediabetes and the metabolic syndrome in crude, but poor concordance in adjusted models.
Topics: Humans; Aged; Prediabetic State; Metabolic Syndrome; Cohort Studies; Cross-Sectional Studies; Risk Factors; Diabetes Mellitus, Type 2; Prevalence
PubMed: 38316913
DOI: 10.1038/s41598-024-53417-1 -
Nature Reviews. Endocrinology Jul 2011Between 25% and 62% of patients with idiopathic peripheral neuropathy are reported to have prediabetes, and among individuals with prediabetes 11-25% are thought to have... (Review)
Review
Between 25% and 62% of patients with idiopathic peripheral neuropathy are reported to have prediabetes, and among individuals with prediabetes 11-25% are thought to have peripheral neuropathy, and 13-21% have neuropathic pain. Population-based studies suggest a gradient for the prevalence of neuropathy, being highest in patients with manifest diabetes mellitus, followed by individuals with impaired glucose tolerance then impaired fasting glucose and least in those with normoglycemia. The most sensitive test to assess glucose metabolism status is the oral glucose tolerance test. Pathogenesis involves hyperglycemia, microvascular abnormalities, dyslipidemia and the metabolic syndrome. Individuals with prediabetes have less severe neuropathy than those with manifest diabetes mellitus. Sensory modalities are more frequently affected than motor modalities, but impairment of small nerve fibers could be the earliest detectable sign. Diagnosis should rely on careful clinical examination, with emphasis on the evaluation of small fibers. An oral glucose tolerance test should be performed in patients with idiopathic neuropathy. The only treatment with any efficacy is lifestyle modification to improve control of hyperglycemia and cardiovascular risk factors, but long-term efficacy of this approach has not been established. This Review summarizes the current evidence on the association between prediabetes and neuropathy.
Topics: Animals; Blood Glucose; Humans; Neuralgia; Peripheral Nervous System Diseases; Polyneuropathies; Prediabetic State; Time Factors
PubMed: 21750507
DOI: 10.1038/nrendo.2011.113