Lipid-induced Insulin ResistanceOVID_FASTINCT06193668
Overfeeding Induced Fat-tissue Stimulation
A study testing High-fat overnutrition and Normocaloric macronutrient-balanced nutrition in people with Lipid-induced Insulin Resistance, run by German Diabetes Center at 1 site in Germany.
Trial summary
Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid-induced Insulin Resistance
- What is being tested?
- High-fat overnutrition and Normocaloric macronutrient-balanced nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years
- BMI < 29 kg/m2
- Sport inactive (<1x /week)
- Capacity to consent
Who cannot join
- Diabetes mellitus disease
- Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation)
- Acute infectious disease
- Taking blood glucose-lowering drugs
- Diseases or drugs affecting the immune system and allergies to drugs used in the study
- Drugs with potential metabolic effects
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- Chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (ALT > 300 U/L))
- Chronic inflammatory bowel diseases
- Rheumatic diseases
- Hyper- or hypothyroidism of the thyroid gland
- Renal insufficiency, administration of iodine-containing contrast media in the last 2 days
- Chronic lung diseases
- cancerous diseases
- Addictive diseases, psychiatric diseases
- Pregnancy, breastfeeding
- Shift workers
- Anemia (Hb <12 g/dl)
- Disorders of hemostasis
- Regular use of antithrombotic drugs
- Alcohol consumption, smoking
- Conditions that do not permit an MRI examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Georgia Xourafa
Düsseldorf, North Rhine-Westphalia, 40225
Georgia Xourafa, MD, +492113382426, georgia.xourafa@ddz.de
Theresia Sarabhai, MD, 0211-3382-0, theresia.Sarabhai@ddz.de
About this study
Official title: Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue
Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.
- Conditions
- Lipid-induced Insulin Resistance
- Being tested
- High-fat overnutrition, Normocaloric macronutrient-balanced nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat overnutritionBehavioural
Overnutrition: 40% higher lipid consumption per day than required
Normocaloric macronutrient-balanced nutritionBehavioural
Normocaloric, macronutrient-balanced nutrition:
Calories requirement for weight maintenance [(kcal/d) 55% carbohydrates, 15% proteins, 30% fat]
| Study group | Role | What they receive |
|---|---|---|
| High-fat overnutrition | Active comparator | Lipid overnutrition: 40% higher lipid consumption per day than required over three weeks. Receives: Behavioral: High-fat overnutrition |
| Normocaloric macronutrient-balanced nutrition | Active comparator | Normocaloric, macronutrient-balanced nutrition per day over three weeks Receives: Behavioral: Normocaloric macronutrient-balanced nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body insulin sensitivity and WAT insulin sensitivity
Hyperinsulinemica-euglycemia clamp tests with deuterated glucose to measure fasting and insulin-stimulated whole-body insulin sensitivity and measurement of the index ADIPO-IR (fasting insulin x free fatty acid concentration) before and after dietary intervention period.
Measured: 3 weeks intervention period each
Secondary outcomes (1)
WAT insulin signaling pathways
Adipose tissue biopsies are planned to be taken during the fasting and insulin-stimulated state before and after the dietary intervention period. DAG and ceramide subcellular fractionation assay is planned to be performed. Expressionanalyses for activation /membrane translocation of novel and atypical protein kinase C isoforms will be done. Determination of the degree of phosphorylation of various components of the insulin pathway via Western blot are planned.
Measured: 3 weeks intervention time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start31 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid-induced 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Study director, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193668
- Sponsor's protocol ID
- OVID-FASTI
- Acronym
- OVID_FASTI
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue
- ClinicalTrials.gov ID
- NCT06193668
- Acronym / sponsor ID
- OVID_FASTI / OVID-FASTI
- Conditions
- Lipid-induced Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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.
Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-fat overnutrition | Active comparator | Behavioral: High-fat overnutritionLipid overnutrition: 40% higher lipid consumption per day than required over three weeks. |
| Normocaloric macronutrient-balanced nutrition | Active comparator | Behavioral: Normocaloric macronutrient-balanced nutritionNormocaloric, macronutrient-balanced nutrition per day over three weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 40 years
- BMI < 29 kg/m2
- Sport inactive (<1x /week)
- Capacity to consent
Key exclusion criteria (21 listed)
- Diabetes mellitus disease
- Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation)
- Acute infectious disease
- Taking blood glucose-lowering drugs
- Diseases or drugs affecting the immune system and allergies to drugs used in the study
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 |
|---|---|---|
| High-fat overnutritionOvernutrition: 40% higher lipid consumption per day than required | Behavioural | High-fat overnutrition |
| Normocaloric macronutrient-balanced nutritionNormocaloric, macronutrient-balanced nutrition: Calories requirement for weight maintenance [(kcal/d) 55% carbohydrates, 15% proteins, 30% fat] | Behavioural | Normocaloric macronutrient-balanced nutrition |
Primary outcome
Whole-body insulin sensitivity and WAT insulin sensitivity
Time frame: 3 weeks intervention period each
Hyperinsulinemica-euglycemia clamp tests with deuterated glucose to measure fasting and insulin-stimulated whole-body insulin sensitivity and measurement of the index ADIPO-IR (fasting insulin x free fatty acid concentration) before and after dietary intervention period.
1 secondary outcome
WAT insulin signaling pathways
Time frame: 3 weeks intervention time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Michael Roden, Prof., MD study director
German Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat overnutrition and Normocaloric macronutrient-balanced nutrition in people with Lipid-induced 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 4 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 1 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresia Sarabhai, MD (0173-9473478 ext. DDZ, theresia.sarabhai@ddz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body insulin sensitivity and WAT insulin sensitivity (time frame: 3 weeks intervention period each). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.