Active clinical trials for "Overweight"

This is a placebo-controlled, randomized, double-blind, parallel arm, multicenter, dose-ranging phase IIb trial to assess glycemic and weight loss efficacy and safety of BMS-646256 in overweight and obese patients with type 2 diabetes who have been treated with diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c >7% and HbA1c<10%).

This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain. Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures: Visit 1 Height and weight measurements. Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors. Visit 2 Physical examination, blood and urine tests. DXA scan to measure body fat, muscle and bone mineral content. Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms. Interview about the child s mood and psychological functioning. Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.

Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism according to recent findings of epidemiological studies in the U.S., Europe, and Japan. However, data from longer-term human intervention studies with appropriate outcome measures are lacking. We will study the effects of caffeinated and decaffeinated coffee consumption on body fatness, insulin sensitivity and glucose tolerance that may underlie the observed associations with a lower risk of type 2 diabetes in a randomized controlled trial. We hypothesize that both caffeinated and decaffeinated coffee will improve insulin sensitivity and glucose tolerance. Before starting a larger, long-term intervention study, we will conduct a pilot study to test the feasibility of such a trial. The pilot study will be an 8-week parallel trial in 45 overweight individuals, who will be randomized to drinking 5 cups per day of 1) caffeinated coffee (n=15), 2) decaffeinated coffee (n=15), or 3) water (n=15). Body fatness (weight, waist circumference, bioelectrical impedance), insulin sensitivity (HOMA model), and glucose tolerance (oral glucose tolerance test) will be the primary outcomes. We will assess the adherence of participants to their assigned treatment by measuring serum caffeine concentrations, documentation of coffee use in diaries by the participants, and counting unused coffee packets. We will also obtain feedback from participants on how to improve compliance in a future trial. If successful, this study will form the basis for a definitive trial of coffee consumption, body fatness, and glucose tolerance. Given the extensive use of coffee and the rapidly increasing health burden of type 2 diabetes, such a trial would have important public health implications.

The purpose of this study is to investigate the effect of a diet with either high or low glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate oxidation after 10 weeks´ intake in slightly overweight subjects.

Patients suffering from diabetes through many years have a risk of developing late diabetic complications including changes in eyes, kidney, vessels and nerves. Late complications can be postponed or avoided when assuring a good diabetes control, i.e. sensible diet, exercise, frequent blood glucose measurements and a good medical treatment. Blood glucose regulation depends on two different factors i.e. the insulin need of the body and the amount of insulin in the body. The amount of insulin, in blood, is decided by the amount of insulin infused daily, whereas the insulin need depends on the patient's weight, physical activity and diet. Overweight type 2 diabetes patients have a large insulin need and especially this need is decisive for their development of diabetes. If these patients are treated with Metformin, blood glucose decreases and the result is an easier weight loss for the patient. Especially, when these patients take this drug, the development of late diabetic complications, especially arteriosclerosis, can be avoided or postponed. Whether these favourable effects of Metformin are also present in type 1 diabetic patients remains to be fully clarified, but some studies have indicated that this is the case. This results in a better regulation of diabetes on a smaller insulin dose than the one given to the patients before. Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing the hepatic glucose production. The drug usually has no side-effects, but some patients do, however, suffer from abdominal pain, small tendency to nausea, loose defaecation and a metallic taste in the mouth. These side-effects are often temporary. Project description In total, 50 type 1 diabetic patients are offered to participate in the project. All are from the outpatient clinic at the Department of Endocrinology. The project lasts 7 months divided as follows: An introductory period of one month introducing an optimisation of the insulin treatment A 6 month period (in which neither the patients nor the treating doctor know which medication is given) with either T. Metformin treatment twice daily or T. Placebo (lime) twice daily together with the usual insulin treatment four times daily. Choice of either T. Metformin or T. Placebo will be made by draw, and as stated above, the drug type will be unknown for both the patient and the treating doctor in order to make sure that the investigation is as objective as possible. Throughout the examination period, the patients are asked to measure blood glucose four times daily, i.e. before main meals and before bed time. These values will be used for regulating the fasting insulin dose with help from the treating doctor, and for adjusting the daily insulin dose. During the first and the last two days of the examination period we will also ask the patients to measure blood glucose at 03h00 for two days. Those diurnal profiles will be included in the evaluation of the blood glucose control during the treatment period. Furthermore, the patients' blood pressures are determined during 24 hours before and after the 6 months' treatment period. This will be carried out automatically by means of a blood pressure cuff around the arm connected to a small apparatus registering the values during 24 hours. The apparatus can be taken home after installation at the outpatient clinic and can be carried around in a belt around the waist until next day where the apparatus will be dismantled. At the first and the last of 5 outpatient visits, blood tests will be taken (for evaluation of the long-term blood glucose, kidney, liver, insulin and fat in blood) and nocturnal urine must be collected and disposed in order to evaluate protein secretion and thereby kidney function.

The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.

This project investigates the effect of regular consumption of commercially available processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety hormones and glycemic response over a 4-week period. We have chosen to provide participants with canned white beans, the most accessible and frequently consumed bean in North America. They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon published literature and short-term studies conducted in our laboratory, we hypothesize that regular consumption of commercially available canned beans will increase satiety and improve the control of food intake, body weight, blood glucose and blood lipids.

This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability. The way the human body processes GSK376501 will also be determined.

Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Recently, an intervention study reported that a diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin sensitivity in healthy subjects. However, additional beneficial effects can be expected from the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a typical Mediterranean diet will even have more pronounced effects. Study objectives: To investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks. Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10. Expected results: Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome.

The objective of this study is to determine the independent and additive effects of food texture and energy density on food and energy intake compared to a control condition.