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CompletedNCT02603237Updated May 6, 2023

Metabolic Response to Fat and Glucose

An interventional study of Glucose tolerance test and Fat tolerance test in Obesity, Insulin Resistance and Healthy, sponsored by Universität des Saarlandes. Completed at 1 site in Germany. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Universität des Saarlandes · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obesity
  • Insulin Resistance
  • Healthy
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 60 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universität des Saarlandes is the lead sponsor of 68 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy volunteers
  • On a stable dietary habits

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Other
    Glucose tolerance test

    All participants will receive an oral standardized glucose tolerance test

    Other: Glucose tolerance test

  • Other
    Fat tolerance test

    The same participants will receive an oral standardized fat load test

    Other: Fat tolerance test

Interventions

  • OtherGlucose tolerance test

    Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load

  • OtherFat 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.

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of Saarland
    Homburg, Saarland 66424, Germany
08

References and documents

Individual participant data

Plan to share: Undecided — will be decided at a later stage

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02603237
Lead sponsor
Universität des Saarlandes
Responsible party
Rima Obeid (Prof. (apl.) Dr., Universität des Saarlandes) — Principal investigator
First posted
Nov 11, 2015
Start date
Jul 2016
Primary completion
Dec 2019
Completion
Jun 2020
Last update
May 6, 2023

Study contacts

Rima Obeid
study director · Universität des Saarlandes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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