Insulin SensitivityGenedietNCT01274091
Gene - Diet Interactions
A study testing PUFA-diet and SAFA-diet in people with Insulin Sensitivity, run by Marjukka Kolehmainen at 1 site in Finland.
Trial summary
Interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- PUFA-diet and SAFA-diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2010to Dec 2011
- Phase
- Interventional
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >20kg/m2 <29kg/m2
- Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism
- participation to METSIM-study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio, principal investigator Markku Laakso)
- normoglycemia
Who cannot join
- type 2 diabetes
- other chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gene-diet Interactions
Interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect on seems to depend on intervention and age. In this study the effects of diets high with saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene.
Aim of the study:
Read more
To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA).
Hypotheses:
- Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary modification, and therefore respond more favorably to PUFA diet
- More general: Dietary instructions individually tailored according to the genotype would allow better treatment of obesity and diabetes
Read the detailed description
Obesity and type 2 diabetes are increasing in all western countries, including Finland. Recent genome wide analyses have found > 30 genes that contribute to either condition.. However, none of these genes explain >5% of the disease risk and altogether they explain < 10% of the total disease risk in cross-sectional studies. Therefore, diet and physical activity are still the major determinants of the risk, as demonstrated by our earlier intervention studies in order to find out the effect of different dietary modifications on glucose and lipid metabolism. More importantly, interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. Unfortunately, gene-environment interaction can only be effectively investigated in intervention studies that are more expensive than cross-sectional population screenings. This leads to a lower sample size and reduced power to detect effects of minor alleles. Despite these limitations the investigators have been able to demonstrate gene-intervention interactions for several genes, including PPARG, in the Finnish Diabetes Prevention study. There is an urgent need for studies investigating effects of tailored diets in individuals selected based on their genotype. This will be the next essential step leading to improved dietary treatments guided by genetic information.
The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect on seems to depend on intervention and age. Based on these findings the investigators created in collaboration with Johan Auwerx an Pro12Ala animal model that demonstrated a differential effect of dietary fat composition depending on the genotype. However, an important conclusive proof that subjects selected based on their Pro12Ala genotype would respond differently to specifically tailored diet modification is still needed.
In this study the effects of diets high with saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene. As a primary endpoint the investigators expect insulin sensitivity to alter differently depending on the genotype. Additionally, a detailed characterization of energy, glucose and lipid metabolism will be performed. Because PPARG gene plays a central role in adipogenesis one of the aims of this study is to find new pathways, genes and gene clusters that are regulated by PPARG in humans.
- Conditions
- Insulin Sensitivity
- Being tested
- PUFA-diet, SAFA-diet
- Keywords
- Gene-diet interaction, PPARgamma gene, Pro12Ala, Fatty acids, Dietary modification, Insulin sensitivity, Glucose metabolism
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUFA-dietOther
Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0.
SAFA-dietOther
Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3.
| Study group | Role | What they receive |
|---|---|---|
| P/S-ratio 1.0 | Experimental | Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates:
polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0. Receives: Other: PUFA-diet |
| P/S-ration 0.3 | Experimental | Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates:. Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3. Receives: Other: SAFA-diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
insulin sensitivity measured by oral glucose tolerance test at the beginning of the first, randomised diet
Measured: week 0
insulin sensitivity
insulin sensitivty measured by oral glucose tolerance test after the first diet
Measured: week 8
insulin sensitivity
Insulin sensitivity measured by oral glucose tolerance test in the beginning of the second, randomised diet
Measured: week 10
insulin sensitivity
insulin sensitivity measured by oral glucose tolerance test after the second diet
Measured: week 18
Secondary outcomes (12)
peripheral blood mononuclear cell gene expression
Measured: week 8
peripheral blood mononuclear cell gene expression
Measured: week 18
serum lipids
serum lipids, including serum lipidomics and fatty acid composition
Measured: week 8
serum lipids
serum lipids, including serum lipidomics and fatty acid composition
Measured: week 18
inflammation
inflammation measured as serum cytokines and adipose tissue inflammation
Measured: week 8
inflammation
inflammation measured as serum cytokines and adipose tissue inflammation
Measured: week 18
energy expenditure
energy expenditure and the rates of substrate oxidation
Measured: week 8
energy expenditure
energy expenditure and the rates of substrate oxidation
Measured: week 18
insulin secretion
Measured: week 8
insulin secretion
Measured: week 18
adipose tissue gene expression
Measured: week 8
adipose tissue gene expression
Measured: week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marjukka Kolehmainen
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor-investigator, Marjukka Kolehmainen, University of Eastern Finland
- Investigators
- Jussi Pihlajamäki, Professor, Principal investigator, University of Eastern Finland, Kuopio University HospitalUrsula S Schwab, Clinical Lect, adjunct prof, Study director, University of Eastern FinlandMatti Uusitupa, Professor, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274091
- Sponsor's protocol ID
- 28//2010
- Acronym
- Genediet
- Status last verified
- Apr 2012
- First submitted
- 10 Jan 2011
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene-diet Interactions
- ClinicalTrials.gov ID
- NCT01274091
- Acronym / sponsor ID
- Genediet / 28//2010
- Conditions
- Insulin Sensitivity
- Keywords
- Gene-diet interaction, PPARgamma gene, Pro12Ala, Fatty acids, Dietary modification, Insulin sensitivity, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marjukka KolehmainenUniversity, hospital or other
- Collaborators
- Kuopio University Hospital
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jan 2011 (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.
Interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect on seems to depend on intervention and age. In this study the effects of diets high with saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene.
Aim of the study:
To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA).
Hypotheses:
- Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary modification, and therefore respond more favorably to PUFA diet
- More general: Dietary instructions individually tailored according to the genotype would allow better treatment of obesity and diabetes
Detailed description
Obesity and type 2 diabetes are increasing in all western countries, including Finland. Recent genome wide analyses have found > 30 genes that contribute to either condition.. However, none of these genes explain >5% of the disease risk and altogether they explain < 10% of the total disease risk in cross-sectional studies. Therefore, diet and physical activity are still the major determinants of the risk, as demonstrated by our earlier intervention studies in order to find out the effect of different dietary modifications on glucose and lipid metabolism. More importantly, interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. Unfortunately, gene-environment interaction can only be effectively investigated in intervention studies that are more expensive than cross-sectional population screenings. This leads to a lower sample size and reduced power to detect effects of minor alleles. Despite these limitations the investigators have been able to demonstrate gene-intervention interactions for several genes, including PPARG, in the Finnish Diabetes Prevention study. There is an urgent need for studies investigating effects of tailored diets in individuals selected based on their genotype. This will be the next essential step leading to improved dietary treatments guided by genetic information.
The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect on seems to depend on intervention and age. Based on these findings the investigators created in collaboration with Johan Auwerx an Pro12Ala animal model that demonstrated a differential effect of dietary fat composition depending on the genotype. However, an important conclusive proof that subjects selected based on their Pro12Ala genotype would respond differently to specifically tailored diet modification is still needed.
In this study the effects of diets high with saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene. As a primary endpoint the investigators expect insulin sensitivity to alter differently depending on the genotype. Additionally, a detailed characterization of energy, glucose and lipid metabolism will be performed. Because PPARG gene plays a central role in adipogenesis one of the aims of this study is to find new pathways, genes and gene clusters that are regulated by PPARG in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P/S-ratio 1.0 | Experimental | Other: PUFA-dietDiets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0. |
| P/S-ration 0.3 | Experimental | Other: SAFA-dietDiets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates:. Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI >20kg/m2 <29kg/m2
- Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism
- participation to METSIM-study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio, principal investigator Markku Laakso)
- normoglycemia
Key exclusion criteria (2 listed)
- type 2 diabetes
- other chronic diseases
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 |
|---|---|---|
| PUFA-dietDiets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0. | Other | P/S-ratio 1.0 |
| SAFA-dietDiets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3. | Other | P/S-ration 0.3 |
Primary outcome
insulin sensitivity
Time frame: week 0
insulin sensitivity measured by oral glucose tolerance test at the beginning of the first, randomised diet
insulin sensitivity
Time frame: week 8
insulin sensitivty measured by oral glucose tolerance test after the first diet
insulin sensitivity
Time frame: week 10
Insulin sensitivity measured by oral glucose tolerance test in the beginning of the second, randomised diet
insulin sensitivity
Time frame: week 18
insulin sensitivity measured by oral glucose tolerance test after the second diet
12 secondary outcomes
peripheral blood mononuclear cell gene expression
Time frame: week 8
peripheral blood mononuclear cell gene expression
Time frame: week 18
serum lipids
Time frame: week 8
serum lipids
Time frame: week 18
inflammation
Time frame: week 8
inflammation
Time frame: week 18
energy expenditure
Time frame: week 8
energy expenditure
Time frame: week 18
insulin secretion
Time frame: week 8
insulin secretion
Time frame: week 18
adipose tissue gene expression
Time frame: week 8
adipose tissue gene expression
Time frame: week 18
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 17 Apr 2012.
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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.
Jussi Pihlajamäki, Professor principal investigator
University of Eastern Finland, Kuopio University Hospital
Ursula S Schwab, Clinical Lect, adjunct prof study director
University of Eastern Finland
Matti Uusitupa, Professor study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUFA-diet and SAFA-diet in people with Insulin Sensitivity, run by Marjukka Kolehmainen at 1 site in Finland.
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 2 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 17 Apr 2012. 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 Finland. 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?
insulin sensitivity (time frame: week 0). The study lists 4 primary outcomes in all. 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 17 Apr 2012.