Insulin ResistanceFFAIRNCT01229059
Free Fatty Acid Induced Insulin Resistance
An observational study of Insulin Resistance, run by German Diabetes Center at 1 site in Germany.
Trial summary
This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Lipovenös lipid infusion
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy, lean non-diabetic humans
Who may be able to join
- non-diabetic (OGTT), no family history of diabetes, BMI<30 kg/m2, age: 20-55 years, no medication
- For the athletes group additionally:
- VO2max > 60ml/kg/min for males and VO2max > 45ml/kg/min for females Active in endurance-exercise activities, 3 times a week for at least 2 years Stable level of training for at least 3 months
Who cannot join
- acute illness within the last 2 weeks, autoimmune diseases, renal insufficiency (creatinine> 1.5 mg/dl), cardiovascular diseases, anemia (Hb< 12g/l), donation of blood within the last 4 weeks before the study, thyroid diseases, pregnancy, smoking, night-shift working (disturbed circadian rhythm), defective coagulation or wound healing, cancer, allergy against soja products
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Assessment of the Time Course of Lipid Induced Insulin Resistance
This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling.
Read the detailed description
Increased availability of free fatty acids impairs glucose disposal in young healthy humans. Patients with type 2 diabetes have reduced whole body glucose disposal, increased ectopic lipid deposition in skeletal muscle and the liver and impaired mitochondrial function. Recent studies suggest that lipid metabolites such as diacylglycerol (DAG), ceramides and long-chain acyl-coA represent the active mediators inducing insulin resistance. Possible targets are DAG-sensitive Proteinkinase C (PKC θ, PKC ε) which inhibit the insulin signaling cascade and ceramides which interfere with the insulin signaling cascade at Proteinkinase B/AKT. Prior studies raised controvesial evidence, thus, it is yet unclear, whether DAG or ceramides are the primary agents inducig lipid-induced insulin resistance. Therefore, the current study aims to explore the time course of the appearance of intramyocellular lipid compunds during lipid infusion in parallel assessing markers of impaired insulin action.
- Conditions
- Insulin Resistance
- Being tested
- Lipovenös lipid infusion
- Keywords
- FFA, insulin resistance, mitochondria
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipovenös lipid infusionDietary supplement
Also called soy oil
Lipid enriched infusions will be applied for 2-6 hours.
| Study group | Role | What they receive |
|---|---|---|
| lipid infusion in untrained humans | healthy lean humans before and after lipid infusion Receives: Dietary Supplement: Lipovenös lipid infusion | |
| lipid infusion in athletes | endurance trained atheletes Receives: Dietary Supplement: Lipovenös lipid infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
intramyocellular lipid metabolites
Muscle biopsies are taken before, after 2.5 and 4 hours of lipid infusion
Measured: after 4 hours lipid infusion
muscle glucose flux
glycogen synthesis rate, glucose-6-phosphate
Measured: during lipid infusion
Secondary outcomes (1)
insulin resistance of glucose uptake and mitochondrial function
Mitochondrial function will bes assessed from muscle biopsy samples taken after 4 hours, insulin sensitivity will be assessed from hyperinsulinemic-euglycemic clamps following 4 hours lipid infusion
Measured: after 4 hours lipid infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229059
- Sponsor's protocol ID
- FFAIR
- Acronym
- FFAIR
- Status last verified
- Aug 2023
- First submitted
- 20 Mar 2010
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Phielix E, Begovatz P, Gancheva S, Bierwagen A, Kornips E, Schaart G, Hesselink MKC, Schrauwen P, Roden M. Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion. JCI Insight. 2019 Nov 1;4(21):e127928. doi: 10.1172/jci.insight.127928.
PubMed 31672941Fritsch M, Koliaki C, Livingstone R, Phielix E, Bierwagen A, Meisinger M, Jelenik T, Strassburger K, Zimmermann S, Brockmann K, Wolff C, Hwang JH, Szendroedi J, Roden M. Time course of postprandial hepatic phosphorus metabolites in lean, obese, and type 2 diabetes patients. Am J Clin Nutr. 2015 Nov;102(5):1051-8. doi: 10.3945/ajcn.115.107599. Epub 2015 Sep 30.
PubMed 26423389
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Time Course of Lipid Induced Insulin Resistance
- ClinicalTrials.gov ID
- NCT01229059
- Acronym / sponsor ID
- FFAIR / FFAIR
- Conditions
- Insulin Resistance
- Keywords
- FFA, insulin resistance, mitochondria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- Mar 2010 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling.
Detailed description
Increased availability of free fatty acids impairs glucose disposal in young healthy humans. Patients with type 2 diabetes have reduced whole body glucose disposal, increased ectopic lipid deposition in skeletal muscle and the liver and impaired mitochondrial function. Recent studies suggest that lipid metabolites such as diacylglycerol (DAG), ceramides and long-chain acyl-coA represent the active mediators inducing insulin resistance. Possible targets are DAG-sensitive Proteinkinase C (PKC θ, PKC ε) which inhibit the insulin signaling cascade and ceramides which interfere with the insulin signaling cascade at Proteinkinase B/AKT. Prior studies raised controvesial evidence, thus, it is yet unclear, whether DAG or ceramides are the primary agents inducig lipid-induced insulin resistance. Therefore, the current study aims to explore the time course of the appearance of intramyocellular lipid compunds during lipid infusion in parallel assessing markers of impaired insulin action.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lipid infusion in untrained humans | – | Dietary Supplement: Lipovenös lipid infusionhealthy lean humans before and after lipid infusion |
| lipid infusion in athletes | – | Dietary Supplement: Lipovenös lipid infusionendurance trained atheletes |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, lean non-diabetic humans
Key inclusion criteria (3 listed)
- non-diabetic (OGTT), no family history of diabetes, BMI<30 kg/m2, age: 20-55 years, no medication
- VO2max > 60ml/kg/min for males and VO2max > 45ml/kg/min for females Active in endurance-exercise activities, 3 times a week for at least 2 years Stable level of training for at least 3 months
Key exclusion criteria (1 listed)
- acute illness within the last 2 weeks, autoimmune diseases, renal insufficiency (creatinine> 1.5 mg/dl), cardiovascular diseases, anemia (Hb< 12g/l), donation of blood within the last 4 weeks before the study, thyroid diseases, pregnancy, smoking, night-shift working (disturbed circadian rhythm), defective coagulation or wound healing, cancer, allergy against soja products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipovenös lipid infusionAlso: soy oilLipid enriched infusions will be applied for 2-6 hours. | Dietary supplement | lipid infusion in athletes, lipid infusion in untrained humans |
Primary outcome
intramyocellular lipid metabolites
Time frame: after 4 hours lipid infusion
Muscle biopsies are taken before, after 2.5 and 4 hours of lipid infusion
muscle glucose flux
Time frame: during lipid infusion
glycogen synthesis rate, glucose-6-phosphate
1 secondary outcome
insulin resistance of glucose uptake and mitochondrial function
Time frame: after 4 hours lipid infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 31672941Phielix E, Begovatz P, Gancheva S, Bierwagen A, Kornips E, Schaart G, Hesselink MKC, Schrauwen P, Roden M. Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion. JCI Insight. 2019 Nov 1;4(21):e127928. doi: 10.1172/jci.insight.127928.
- Derived from this study: PubMed 26423389Fritsch M, Koliaki C, Livingstone R, Phielix E, Bierwagen A, Meisinger M, Jelenik T, Strassburger K, Zimmermann S, Brockmann K, Wolff C, Hwang JH, Szendroedi J, Roden M. Time course of postprandial hepatic phosphorus metabolites in lean, obese, and type 2 diabetes patients. Am J Clin Nutr. 2015 Nov;102(5):1051-8. doi: 10.3945/ajcn.115.107599. Epub 2015 Sep 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Roden, Prof., MD principal investigator
German Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by German Diabetes Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intramyocellular lipid metabolites (time frame: after 4 hours lipid infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01229059, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.