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Pre-Diabetic clinical trials

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NCT ID: NCT03708419 Completed - Obesity Clinical Trials

Personalized Glucose Optimization Through Nutritional Intervention

PERSON
Start date: June 4, 2018
Phase: N/A
Study type: Interventional

Maintaining well-controlled blood glucose concentrations is essential in the prevention of chronic cardiometabolic diseases. The blood glucose response to dietary and/or lifestyle patterns may vary between individuals. Insulin resistance in specific metabolic organs such as skeletal muscle, adipose tissue or the liver may underlie differential blood glucose responses. This dietary intervention study aims to obtain insight into the metabolic and lifestyle determinants of postprandial blood glucose responses, and to establish the effect of macronutrient manipulation of a 12-week dietary intervention on blood glucose homeostasis in metabolically different subgroups an its relationship to physical and mental performance and well-being.

NCT ID: NCT02756117 Completed - Healthy Clinical Trials

The Effect of Acute Lysine Administration on α-aminoadipic Acid

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.

NCT ID: NCT02482922 Completed - Obesity Clinical Trials

Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors

IETnutrition
Start date: May 2015
Phase: N/A
Study type: Interventional

Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise training (IET) and nutrition program, as well as its preliminary effects on resting heart rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among primary care patients who have at least one risk factor for cardiovascular disease (CVD). Participants : 30 patients who receive care from the University of North Carolina (UNC) Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC patients, not diagnosed with severe illness), will be enrolled to test the feasibility of the home-based interval exercise and nutrition program. Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In Phase I, 15 patients will be enrolled into the program, which will take approximately 3 months. At baseline, data will be collected on age, height, weight, resting heart rate, blood pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin, percent body fat, cardiovascular fitness, and use a series of questionnaires to evaluate mood, sleep, hunger, and quality of life. At closeout, the investigators will measure patients' adherence to each component of the intervention. In Phase II, an additional 15 new patients will be enrolled in either the identical protocol, or a slightly modified intervention (if necessary based upon our results from Phase I). All patients will have the same variables measured at baseline during their study visit at 3, 6 and 12 months after enrollment into the study.

NCT ID: NCT02124590 Completed - Elderly Clinical Trials

The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function

Start date: June 2014
Phase: N/A
Study type: Interventional

This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise provides more improvements in glucose control for pre-diabetic patients than vigorous intensity. The investigators hypothesize that moderate intensity exercise might be beneficial for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging excess protein acetylation (measured in muscle biopsy), 2. Improving the acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend to use the results of this study to show feasibility in measuring mitochondrial function at Duke for a larger federal grant submission. Investigators hypothesize that carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments in glucose tolerance and insulin action.

NCT ID: NCT01980017 Completed - Pre-diabetic Clinical Trials

Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs

OMSCinDEP
Start date: July 2013
Phase: N/A
Study type: Interventional

The incidence of type 2 diabetes mellitus (T2DM) is increasing rapidly. The combination of T2DM and smoking is particularly lethal, as smokers with T2DM are significantly more likely to develop a number of health related complications. Community-based diabetes education programs (DEPs) have been developed to support patient self-care behaviours (e.g. adherence to oral medications, insulin therapy, nutrition management, regular blood glucose monitoring, and physical activity); however, specific assistance for smoking cessation is rarely provided. Our investigative team has developed a knowledge transfer and practice change process to introduce evidence-based interventions for smoking cessation into clinical practice settings. This process is known as the Ottawa Model for Smoking Cessation (OMSC). Investigators believe there is an opportunity to use the OMSC intervention to dramatically enhance the effectiveness of DEPs in addressing smoking cessation among smokers with T2DM, and in so doing, improve quit rates in this high risk population. The purpose of this project is to evaluate the effectiveness of the Ottawa Model for Smoking Cessation (OMSC) intervention in multiple diabetes education programs (DEPs) in Ontario. A two-level recruitment strategy will be employed. Eighteen DEPs will be recruited, and then a consecutive sample of eligible smoker-patients will be recruited from each DEP over a 6-month recruitment period. Investigators want to test the impact of the OMSC intervention on quit rates among smokers with diabetes and pre-diabetes referred to these programs. Investigators will conduct a matched-pair cluster design trial at 18 DEPs in Ontario. These sites will be matched based on number of annual referrals for diabetes education (≤ 500/year or > 500/year). Within each pair, sites will be allocated randomly to either OMSC intervention or control group. Following randomization, the OMSC program will be implemented at the intervention sites over a 6-month period. Following the implementation period, a consecutive sample of smokers will be recruited from both OMSC intervention and control DEPs over a 6-month recruitment period. It is estimated that this will yield a sample of approximately 445 smokers in each of the OMSC intervention and control groups. The primary outcome will be the biochemically-validated 7-day point prevalence abstinence rate six months after an index visit to the DEP. Secondary outcomes will include: rates of identification and intervention of smokers, and diabetes educators' attitudes, confidence, and perceptions of barriers and facilitators to implementing smoking cessation support as part of routine care. If proven effective, the OMSC is appropriate for implementation in DEPs across Canada and could have profound impacts on patient and community health.

NCT ID: NCT01944904 Completed - Pre-diabetic Clinical Trials

Investigation of the Ability of a Supplement to Increase Good Bacteria in the Human Intestine and Blood Sugar Levels

XOS2
Start date: September 2013
Phase: N/A
Study type: Interventional

This study aims to determine whether the use of a supplement called xylooligosaccharide (XOS) increases the number of good bacteria that live in human intestines and can maintain healthy blood sugar levels, and whether XOS has any unpleasant or unexpected side effects when consumed at different dosages. Subjects who participate in this study will be randomized to receive an eight week supply of either a lower dose of XOS or placebo (no active substance). This will be determined randomly, in a process similar to flipping a coin. Blood samples will be taken at each visits, including an oral glucose tolerance test. Subjects will also be asked to collect and bring in stool samples at three different time points during the study. Subjects will have a 50/50 chance of being assigned to the either study group. This is a double-blind study which means neither the study investigator nor the subject will know to which group he/she has been assigned. In case of an emergency, the study doctor can get this information.

NCT ID: NCT01724736 Completed - Pre Diabetic Clinical Trials

A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome

Start date: November 2012
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and satiety.

NCT ID: NCT01579292 Completed - Physical Activity Clinical Trials

A Mobile Based Diabetes Prevention Program

Start date: May 2012
Phase: N/A
Study type: Interventional

The goals of the study are to: 1. Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to a control group. 2. To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage. 3. To conduct process evaluation to gain insights into patient compliance to the mobile intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months using a semi-structured interview method.

NCT ID: NCT01411540 Completed - Obesity Clinical Trials

Effects of a Wholegrain Diet on Body Composition and Energy Balance

Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to compare a diet containing whole grains versus an energy matched diet using refined grains on body composition and metabolism.