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Tolerance clinical trials

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NCT ID: NCT02586636 Completed - Tolerance Clinical Trials

Impact of OCT1 on Metformin Tolerance

ImpOCT
Start date: March 2016
Phase: Phase 4
Study type: Interventional

Metformin is the first-line treatment for medical management of Type 2 Diabetes. Up to 25% of patients experience significant gastrointestinal symptoms and in approximate 5%, side-effects result in the discontinuation of metformin. It would be of great clinical significance if the underlying cause of this intolerance was identified. Recent data has highlighted a metformin transporter in the gut - Organic Cation Transporter 1(OCT1) - as a potential culprit for the variability in metformin tolerance. Across a diabetic population, up to one in four people were shown to have a single reduced function allele for OCT1, with approximately 8% having two reduced function alleles. This may increase the risk of the individual experiencing metformin-associated side-effects, potentially due to accumulation within the cells lining the intestine. The investigators aim to show that loss of function of OCT1, either due to genetic variation or drug inhibition of OCT1, may lead to an increase in the symptoms associated with metformin intolerance. The study is being undertaken at the Clinical Research Centre in Ninewells Hospital, Dundee. The investigators will recruit participants from the GoDARTS study (Genetics of Diabetes and Audit Research Tayside Study). The participants will be healthy controls, i.e. non-diabetic, and recruited according to their genotype of OCT1 (information from GoDARTS). The volunteers will then enter a matched cross-over study with two treatment periods. Metformin is taken during both treatment periods alongside either Omeprazole (a proton pump inhibitor used to prevent excess stomach acid, known to interact with OCT1) or placebo. The metformin dose is increased gradually during each period, to a maximum tolerated dose. The investigators expect to see a lower maximum tolerated dose in individuals with loss of function genotype, or in those taking concurrent omeprazole compared to placebo. The study will last approximately 9 weeks. Volunteers have 3 visits to the CRC, and weekly phone call interviews.

NCT ID: NCT02340143 Completed - Tolerance Clinical Trials

Assessing Early Behavioral Indicators of Formula Tolerance

Start date: January 2015
Phase: N/A
Study type: Interventional

The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

NCT ID: NCT02307773 Completed - Tolerance Clinical Trials

Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

Start date: November 2013
Phase: N/A
Study type: Observational

The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.

NCT ID: NCT02144402 Completed - Infant Development Clinical Trials

Growth of Healthy Term Infants Fed Formula Containing DHA-B

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

The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.

NCT ID: NCT02129296 Recruiting - Weight Loss Clinical Trials

Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

NCT ID: NCT02091349 Completed - Tolerance Clinical Trials

Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber

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

The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.

NCT ID: NCT02016703 Completed - Tolerance Clinical Trials

Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

Start date: March 2006
Phase: N/A
Study type: Interventional

Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.

NCT ID: NCT01946841 Withdrawn - Quality of Life Clinical Trials

Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

AL-EN-PHED
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

NCT ID: NCT01925560 Completed - Tolerance Clinical Trials

Tolerance and Utilization of Agave Inulin in Healthy Adults

Start date: January 2013
Phase: N/A
Study type: Interventional

The objective of this study is to assess the tolerance and utilization of agave inulin. This will be accomplished through analyses of breath and fecal samples to quantify fermentation end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial populations will also be measured in fecal samples.

NCT ID: NCT01909661 Completed - Tolerance Clinical Trials

Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

JUNGLO
Start date: March 2013
Phase: Phase 2
Study type: Interventional

The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.