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Metabolic Response to Fat and Glucose

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ClinicalTrials.gov Identifier: NCT02603237
Recruitment Status : Unknown
Verified May 2018 by Rima Obeid, Saarland University.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Rima Obeid, Saarland University

Brief Summary:
The study will compare plasma and urine post-prandial metabolomics after fat and glucose oral load according to lifestyle factors.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Healthy Other: Glucose tolerance test Other: Fat tolerance test Not Applicable

Detailed Description:
The metabolic response in plasma and urine, pre- and post-load tests in people with specific dietary lifestyles will be tested. This project will focus on fat and glucose induced changes of targeted metabolic pathways that have been related to diabetes and obesity risk.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Metabolic Response to Fat and Glucose
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Glucose tolerance test
All participants will receive an oral standardized glucose tolerance test
Other: Glucose tolerance test
Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load

Fat tolerance test
The same participants will receive an oral standardized fat load test
Other: Fat tolerance test
Oral fat tolerance will be provided to fasting participants and blood samples will be collected before and 4 hrs after the fat load.




Primary Outcome Measures :
  1. Plasma levels of branched chain amino acid [ Time Frame: Changes between baseline and 2 hours ]
  2. Plasma Trimethylamin N-oxide [ Time Frame: Changes between baseline and 2 hours ]
  3. Plasma glucose level [ Time Frame: Changes between baseline and 2 hours ]
  4. Plasma glucose [ Time Frame: Changes between baseline and 2 hours ]
  5. Plasma level of acetyl-CoA [ Time Frame: Changes between baseline and 2 hours ]

Secondary Outcome Measures :
  1. Plasma malonyl-CoA [ Time Frame: Changes between baseline and 2 hours ]
  2. Plasma phosphatidylcholine [ Time Frame: Changes between baseline and 2 hours ]
  3. Plasma insulin [ Time Frame: Changes between baseline and 2 hours ]
  4. Plasma leptin [ Time Frame: Changes between baseline and 2 hours ]
  5. Plasma Lactate [ Time Frame: Changes between baseline and 2 hours ]
  6. Plasma pyruvate [ Time Frame: Changes between baseline and 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • On a stable dietary habits

Exclusion Criteria:

  • Pregnancy
  • Malabsorption disorders
  • Present or former cancer
  • Any oral medication that affect glucose or fat absorptions
  • Cholesterol lowering drugs (i.e. Statins)
  • other drugs: fibrates, MTX, or vitamin supplements
  • Diabetes (type 1 and type 2)
  • Alcoholism
  • Weight losing diet during the last 4 months
  • Liver diseases
  • Renal dysfunction
  • Gastric resection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603237


Locations
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Germany
University of Saarland
Homburg, Saarland, Germany, 66424
Sponsors and Collaborators
Saarland University
Investigators
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Study Director: Rima Obeid Saarland University
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Responsible Party: Rima Obeid, Prof. (apl.) Dr., Saarland University
ClinicalTrials.gov Identifier: NCT02603237    
Other Study ID Numbers: Postprandial metabolomics
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: will be decided at a later stage
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases