ObesityPPAR-NAPASNCT04436419
Immunometabolic Effects of Non-drug Strategies in the Clinical Management of Obesity: Translational Study
A study testing Alpha lipoic acid (plus full hospitalization) in people with Obesity and Obesity, Abdominal, run by Fauqué at 1 site in France.
Trial summary
Forty women aged between 18 and 75 years-old with a BMI> 30kg/m2 are recruited to participate in the evaluation of their medical management. They participate in an 8-week protocol as part of hospital medical treatment for weight loss at the Oxford Polyclinic in Cannes (IPOCA). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Obesity, Obesity, Abdominal, Obesity, Visceral
- What is being tested?
- Alpha lipoic acid (plus full hospitalization)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2018to 16 Mar 2020
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI> 30; aged between 18 and 75 years
Who cannot join
- Pregnant and/or lactating women; not affiliated with social security; not mutual health insurance; person deprived of liberty; participation in clinical research in the last 6 months
- Non-inclusion criteria:
- HLA-DRB1*04-03/06 polymorphisms; recent hospitalization (<1 month); food supplement based on antioxidant; medicated in fibrate/telmisartan (modulator of PPARs)
Trial locations and contacts
1 site in 1 country.
About this study
Forty women aged between 18 and 75 years-old with a BMI> 30kg/m2 are recruited to participate in the evaluation of their medical management. They participate in an 8-week protocol as part of hospital medical treatment for weight loss at the Oxford Polyclinic in Cannes (IPOCA). The effects of 2 independent variables will be studied: (1) an adapted physical activity program and (2) nutritional supplementation with R-α-Lipoic acid (2x300mg/d) versus placebo (double-blind). The volunteers are randomly assigned to the different groups: Placebo with or without exercise groups and ALA with or without exercise groups. At the start of the protocol (T0), at 4 weeks (T4) and at 8 weeks (T8), various measurements are carried out (physical capacities, nutritional status, body composition, distribution of adipose mass by CT-scan). A venous sample taken for all participants is done at T0, T4 and T8 to investigate the immune profile of circulating T lymphocytes.
This project is part of a translational research project to assess current care and to investigate the immunometabolic effects of a non-drug medical care of obesity (adapted physical activities, nutritional supplementation with α-lipoic acid, quality of food intake).
Read the detailed description
Obesity-related inflammation is central to the development of type 2 diabetes and potentiated by advancing age, inactive behavior and sedentary lifestyle. Metabolism and immunity are entangled in their respective effects: the pathways of inflammation are involved in metabolism and the metabolic state plays a predominant role in immune function. Physical activity and calorie restriction are first-line, non-drug strategies recommended in reducing obesity and insulin resistance and then prevent type 2 diabetes. However, the impact of their combined effects on circulating immune cells or those residing in adipose tissue and skeletal muscle, remains insufficiently understood to allow a nutritional prescription (i.e., quality of nutritional intake and efficient doses of physical activity) favorable to preventive medical care, individualized, and effective. If the risk associated with an increase in visceral fat mass is linked to a change in the pro/anti-inflammatory status, it is essential to reduce this risk by acting on its cause, regardless of the weight loss. In a context of low-grade inflammation, these effects could lead to an anti-inflammatory profile of T cells, specifically regulatory T cells (Treg) whose metabolism is extremely "flexible" at the periphery and into visceral adipose tissue (directly involved in inflammation of obesity).
ALA (Alpha-Lipoic Acid) is known to play a pivotal role in cellular redox status and energy metabolism by modulating inflammatory and metabolic signaling pathways such as those of NF-kB, JNK, PI3K/Akt, p38 MAPK, AMPK or PPARβ/δ. As ALA is a possible metabolic modulator, it would affect the metabolism of T cells. And therefore ALA could be a complementary measure to non-drug strategies by potentiating the correction of the inflammatory state linked to obesity.
- Conditions
- Obesity, Obesity, Abdominal, Obesity, Visceral, Female
- Being tested
- Alpha lipoic acid (plus full hospitalization), Placebo (full hospitalization: dietary monitoring with an adapted physical activity program)
- Keywords
- Regulatory T cells, Immunometabolic, Alpha lipoic acid, Physical activity, Non-drug strategy, Obesity
- Medical subject headings
- Obesity, Obesity, Abdominal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acid (plus full hospitalization)Dietary supplement
Women are included in an 8-weeks randomized double-blind against placebo supplementation study with ALA (eight per group) according to the following criteria:
Inclusion criteria: BMI> 30; aged between 18 and 75 years. Non-inclusion criteria: HLA-DRB1*04-03/06 polymorphisms; recent hospitalization (<1 month); food supplement based on antioxidant; medicated in fibrate / telmisartan (modulator of PPARs); patients presenting an acute inflammatory state.
Exclusion criteria: Pregnant and/or lactating women; not affiliated with social security; not mutual health insurance; person deprived of liberty; participation in clinical research in the last 6 months.
Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. α-LA (2x300mg/day of R-ALA) was administered double-blinded in the form of 2 capsules apart from meals.
Placebo (full hospitalization: dietary monitoring with an adapted physical activity program)Dietary supplement
Women are included in an 8-weeks randomized in placebo group. Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. Placebo (2x300mg/day) was administered double-blinded in the form of 2 capsules apart from meals.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients benefited from a complete hospitalization including dietary monitoring (food intake was controlled in order to provide 30% less of their estimated daily energy expenditure) with a personalized food plan and an adapted physical activity program (5 sessions per week supervised by a graduated health physical activity coach), plus placebo administration (2x per day) apart from meal. Receives: Dietary Supplement: Placebo (full hospitalization: dietary monitoring with an adapted physical activity program) |
| ALA | Active comparator | Patients benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program, plus R-ALA enantiomer administration (2x300mg per day) apart from meal. Receives: Dietary Supplement: Alpha lipoic acid (plus full hospitalization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the prevalence of regulatory T cells from Peripheral Blood Mononuclear Cells (PBMCs) drawn from whole blood at the beginning (T0), mid-course (T4) and the end of the course (T8).
Cells were gently washed twice and resuspended in PBS. Stained cell preparations were analyzed using a BD FACS Canto II flow cytometer. The staining and gating strategy were used for traited human PBMCs by utilizing CD3+, CD4+, CD25+ and FoxP3+ antibodies. We have discriminated CD3+CD4+ versus CD3+CD4-. Finally, at this stage CD25+FoxP3+ (Regulatory T cells) cells were gated as part of the CD3+CD4+ population.
Measured: Through study completion, an average of 2 months
60% increasing in PPARβ/δ expression, estimated from the level of expression of its main target gene CPT1a, in human PBMC between the beginning (T0) and end of the course (T8).
Total mRNA was extracted with Trizol reagent and the relative amount of CPT1a mRNA was calculated using the comparative ΔΔCT method after quantitative RT-PCR analysis.
Measured: Through study completion, an average of 2 months
Improvement of Redox status by measuring GSH/GSSH ratio in human whole blood between the beginning (T0) and end of the course (T8).
The GSH/GSSG Assay is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).
Measured: Through study completion, an average of 3 months
Secondary outcomes (1)
Reduction of the area from visceral adipose tissue measured by computed-tomography scan between the beginning (T0) and end of the course (T8).
A computed-tomography scan (CT-scan) which allowed to discriminate the area of subcutaneous adipose tissue from visceral fatty area (VFA) was calculated from x-ray performed at the third lumbar level. Visceral abdominal adipose tissue was estimated by subtracting total abdominal and subcutaneous adipose tissues areas.
Measured: Through study completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start2 Jul 2018
- Primary completion28 Feb 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fauqué
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Polyclinique de Cannes (IPOCA)
- Responsible party
- Sponsor-investigator, Fauqué, Institut Polyclinique de Cannes (IPOCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436419
- Sponsor's protocol ID
- 3573-I
- Acronym
- PPAR-NAPAS
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gleeson M, Bishop NC, Stensel DJ, Lindley MR, Mastana SS, Nimmo MA. The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease. Nat Rev Immunol. 2011 Aug 5;11(9):607-15. doi: 10.1038/nri3041.
PubMed 21818123Mothe-Satney I, Murdaca J, Sibille B, Rousseau AS, Squillace R, Le Menn G, Rekima A, Larbret F, Pele J, Verhasselt V, Grimaldi PA, Neels JG. A role for Peroxisome Proliferator-Activated Receptor Beta in T cell development. Sci Rep. 2016 Sep 29;6:34317. doi: 10.1038/srep34317.
PubMed 27680392Rousseau AS, Sibille B, Murdaca J, Mothe-Satney I, Grimaldi PA, Neels JG. alpha-Lipoic acid up-regulates expression of peroxisome proliferator-activated receptor beta in skeletal muscle: involvement of the JNK signaling pathway. FASEB J. 2016 Mar;30(3):1287-99. doi: 10.1096/fj.15-280453. Epub 2015 Dec 9.
PubMed 26655383Le Garf S, Murdaca J, Mothe-Satney I, Sibille B, Le Menn G, Chinetti G, Neels JG, Rousseau AS. Complementary Immunometabolic Effects of Exercise and PPARbeta/delta Agonist in the Context of Diet-Induced Weight Loss in Obese Female Mice. Int J Mol Sci. 2019 Oct 19;20(20):5182. doi: 10.3390/ijms20205182.
PubMed 31635041Namazi N, Larijani B, Azadbakht L. Alpha-lipoic acid supplement in obesity treatment: A systematic review and meta-analysis of clinical trials. Clin Nutr. 2018 Apr;37(2):419-428. doi: 10.1016/j.clnu.2017.06.002. Epub 2017 Jun 8.
PubMed 28629898Cui J, Huang D, Zheng Y. Ameliorative effects of alpha-lipoic acid on high-fat diet-induced oxidative stress and glucose uptake impairment of T cells. Free Radic Res. 2016 Oct;50(10):1106-1115. doi: 10.1080/10715762.2016.1210140. Epub 2016 Aug 4.
PubMed 27383289Berod L, Friedrich C, Nandan A, Freitag J, Hagemann S, Harmrolfs K, Sandouk A, Hesse C, Castro CN, Bahre H, Tschirner SK, Gorinski N, Gohmert M, Mayer CT, Huehn J, Ponimaskin E, Abraham WR, Muller R, Lochner M, Sparwasser T. De novo fatty acid synthesis controls the fate between regulatory T and T helper 17 cells. Nat Med. 2014 Nov;20(11):1327-33. doi: 10.1038/nm.3704. Epub 2014 Oct 5.
PubMed 25282359Kempkes RWM, Joosten I, Koenen HJPM, He X. Metabolic Pathways Involved in Regulatory T Cell Functionality. Front Immunol. 2019 Dec 3;10:2839. doi: 10.3389/fimmu.2019.02839. eCollection 2019.
PubMed 31849995Newton R, Priyadharshini B, Turka LA. Immunometabolism of regulatory T cells. Nat Immunol. 2016 May 19;17(6):618-25. doi: 10.1038/ni.3466.
PubMed 27196520Zou J, Lai B, Zheng M, Chen Q, Jiang S, Song A, Huang Z, Shi P, Tu X, Wang D, Lu L, Lin Z, Gao X. CD4+ T cells memorize obesity and promote weight regain. Cell Mol Immunol. 2018 Jun;15(6):630-639. doi: 10.1038/cmi.2017.36. Epub 2017 Jun 19.
PubMed 28626237
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunometabolic Effects of Non-drug Strategies in the Clinical Management of Obesity: Translational Study
- ClinicalTrials.gov ID
- NCT04436419
- Acronym / sponsor ID
- PPAR-NAPAS / 3573-I
- Conditions
- Obesity, Obesity, Abdominal, Obesity, Visceral, Female
- Keywords
- Regulatory T cells, Immunometabolic, Alpha lipoic acid, Physical activity, Non-drug strategy, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- FauquéIndustry (pharma, biotech, devices)
- Collaborators
- Institut Polyclinique de Cannes (IPOCA)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 18 Jun 2020 (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.
Forty women aged between 18 and 75 years-old with a BMI> 30kg/m2 are recruited to participate in the evaluation of their medical management. They participate in an 8-week protocol as part of hospital medical treatment for weight loss at the Oxford Polyclinic in Cannes (IPOCA). The effects of 2 independent variables will be studied: (1) an adapted physical activity program and (2) nutritional supplementation with R-α-Lipoic acid (2x300mg/d) versus placebo (double-blind). The volunteers are randomly assigned to the different groups: Placebo with or without exercise groups and ALA with or without exercise groups. At the start of the protocol (T0), at 4 weeks (T4) and at 8 weeks (T8), various measurements are carried out (physical capacities, nutritional status, body composition, distribution of adipose mass by CT-scan). A venous sample taken for all participants is done at T0, T4 and T8 to investigate the immune profile of circulating T lymphocytes.
This project is part of a translational research project to assess current care and to investigate the immunometabolic effects of a non-drug medical care of obesity (adapted physical activities, nutritional supplementation with α-lipoic acid, quality of food intake).
Detailed description
Obesity-related inflammation is central to the development of type 2 diabetes and potentiated by advancing age, inactive behavior and sedentary lifestyle. Metabolism and immunity are entangled in their respective effects: the pathways of inflammation are involved in metabolism and the metabolic state plays a predominant role in immune function. Physical activity and calorie restriction are first-line, non-drug strategies recommended in reducing obesity and insulin resistance and then prevent type 2 diabetes. However, the impact of their combined effects on circulating immune cells or those residing in adipose tissue and skeletal muscle, remains insufficiently understood to allow a nutritional prescription (i.e., quality of nutritional intake and efficient doses of physical activity) favorable to preventive medical care, individualized, and effective. If the risk associated with an increase in visceral fat mass is linked to a change in the pro/anti-inflammatory status, it is essential to reduce this risk by acting on its cause, regardless of the weight loss. In a context of low-grade inflammation, these effects could lead to an anti-inflammatory profile of T cells, specifically regulatory T cells (Treg) whose metabolism is extremely "flexible" at the periphery and into visceral adipose tissue (directly involved in inflammation of obesity).
ALA (Alpha-Lipoic Acid) is known to play a pivotal role in cellular redox status and energy metabolism by modulating inflammatory and metabolic signaling pathways such as those of NF-kB, JNK, PI3K/Akt, p38 MAPK, AMPK or PPARβ/δ. As ALA is a possible metabolic modulator, it would affect the metabolism of T cells. And therefore ALA could be a complementary measure to non-drug strategies by potentiating the correction of the inflammatory state linked to obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo (full hospitalization: dietary monitoring with an adapted physical activity program)Patients benefited from a complete hospitalization including dietary monitoring (food intake was controlled in order to provide 30% less of their estimated daily energy expenditure) with a personalized food plan and an adapted physical activity program (5 sessions per week supervised by a graduated health physical activity coach), plus placebo administration (2x per day) apart from meal. |
| ALA | Active comparator | Dietary Supplement: Alpha lipoic acid (plus full hospitalization)Patients benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program, plus R-ALA enantiomer administration (2x300mg per day) apart from meal. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI> 30; aged between 18 and 75 years
Key exclusion criteria (3 listed)
- Pregnant and/or lactating women; not affiliated with social security; not mutual health insurance; person deprived of liberty; participation in clinical research in the last 6 months
- HLA-DRB1*04-03/06 polymorphisms; recent hospitalization (<1 month); food supplement based on antioxidant; medicated in fibrate/telmisartan (modulator of PPARs)
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 |
|---|---|---|
| Alpha lipoic acid (plus full hospitalization)Women are included in an 8-weeks randomized double-blind against placebo supplementation study with ALA (eight per group) according to the following criteria: Inclusion criteria: BMI> 30; aged between 18 and 75 years. Non-inclusion criteria: HLA-DRB1*04-03/06 polymorphisms; recent hospitalization (<1 month); food supplement based on antioxidant; medicated in fibrate / telmisartan (modulator of PPARs); patients presenting an acute inflammatory state. Exclusion criteria: Pregnant and/or lactating women; not affiliated with social security; not mutual health insurance; person deprived of liberty; participation in clinical research in the last 6 months. Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. α-LA (2x300mg/day of R-ALA) was administered double-blinded in the form of 2 capsules apart from meals. | Dietary supplement | ALA |
| Placebo (full hospitalization: dietary monitoring with an adapted physical activity program)Women are included in an 8-weeks randomized in placebo group. Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. Placebo (2x300mg/day) was administered double-blinded in the form of 2 capsules apart from meals. | Dietary supplement | Placebo |
Primary outcome
Variation in the prevalence of regulatory T cells from Peripheral Blood Mononuclear Cells (PBMCs) drawn from whole blood at the beginning (T0), mid-course (T4) and the end of the course (T8).
Time frame: Through study completion, an average of 2 months
Cells were gently washed twice and resuspended in PBS. Stained cell preparations were analyzed using a BD FACS Canto II flow cytometer. The staining and gating strategy were used for traited human PBMCs by utilizing CD3+, CD4+, CD25+ and FoxP3+ antibodies. We have discriminated CD3+CD4+ versus CD3+CD4-. Finally, at this stage CD25+FoxP3+ (Regulatory T cells) cells were gated as part of the CD3+CD4+ population.
60% increasing in PPARβ/δ expression, estimated from the level of expression of its main target gene CPT1a, in human PBMC between the beginning (T0) and end of the course (T8).
Time frame: Through study completion, an average of 2 months
Total mRNA was extracted with Trizol reagent and the relative amount of CPT1a mRNA was calculated using the comparative ΔΔCT method after quantitative RT-PCR analysis.
Improvement of Redox status by measuring GSH/GSSH ratio in human whole blood between the beginning (T0) and end of the course (T8).
Time frame: Through study completion, an average of 3 months
The GSH/GSSG Assay is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).
1 secondary outcome
Reduction of the area from visceral adipose tissue measured by computed-tomography scan between the beginning (T0) and end of the course (T8).
Time frame: Through study completion, an average of 1 months
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 24 Jun 2020.
- Background: PubMed 21818123Gleeson M, Bishop NC, Stensel DJ, Lindley MR, Mastana SS, Nimmo MA. The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease. Nat Rev Immunol. 2011 Aug 5;11(9):607-15. doi: 10.1038/nri3041.
- Background: PubMed 27680392Mothe-Satney I, Murdaca J, Sibille B, Rousseau AS, Squillace R, Le Menn G, Rekima A, Larbret F, Pele J, Verhasselt V, Grimaldi PA, Neels JG. A role for Peroxisome Proliferator-Activated Receptor Beta in T cell development. Sci Rep. 2016 Sep 29;6:34317. doi: 10.1038/srep34317.
- Background: PubMed 26655383Rousseau AS, Sibille B, Murdaca J, Mothe-Satney I, Grimaldi PA, Neels JG. alpha-Lipoic acid up-regulates expression of peroxisome proliferator-activated receptor beta in skeletal muscle: involvement of the JNK signaling pathway. FASEB J. 2016 Mar;30(3):1287-99. doi: 10.1096/fj.15-280453. Epub 2015 Dec 9.
- Background: PubMed 31635041Le Garf S, Murdaca J, Mothe-Satney I, Sibille B, Le Menn G, Chinetti G, Neels JG, Rousseau AS. Complementary Immunometabolic Effects of Exercise and PPARbeta/delta Agonist in the Context of Diet-Induced Weight Loss in Obese Female Mice. Int J Mol Sci. 2019 Oct 19;20(20):5182. doi: 10.3390/ijms20205182.
- Background: PubMed 28629898Namazi N, Larijani B, Azadbakht L. Alpha-lipoic acid supplement in obesity treatment: A systematic review and meta-analysis of clinical trials. Clin Nutr. 2018 Apr;37(2):419-428. doi: 10.1016/j.clnu.2017.06.002. Epub 2017 Jun 8.
- Background: PubMed 27383289Cui J, Huang D, Zheng Y. Ameliorative effects of alpha-lipoic acid on high-fat diet-induced oxidative stress and glucose uptake impairment of T cells. Free Radic Res. 2016 Oct;50(10):1106-1115. doi: 10.1080/10715762.2016.1210140. Epub 2016 Aug 4.
- Background: PubMed 25282359Berod L, Friedrich C, Nandan A, Freitag J, Hagemann S, Harmrolfs K, Sandouk A, Hesse C, Castro CN, Bahre H, Tschirner SK, Gorinski N, Gohmert M, Mayer CT, Huehn J, Ponimaskin E, Abraham WR, Muller R, Lochner M, Sparwasser T. De novo fatty acid synthesis controls the fate between regulatory T and T helper 17 cells. Nat Med. 2014 Nov;20(11):1327-33. doi: 10.1038/nm.3704. Epub 2014 Oct 5.
- Background: PubMed 31849995Kempkes RWM, Joosten I, Koenen HJPM, He X. Metabolic Pathways Involved in Regulatory T Cell Functionality. Front Immunol. 2019 Dec 3;10:2839. doi: 10.3389/fimmu.2019.02839. eCollection 2019.
- Background: PubMed 27196520Newton R, Priyadharshini B, Turka LA. Immunometabolism of regulatory T cells. Nat Immunol. 2016 May 19;17(6):618-25. doi: 10.1038/ni.3466.
- Background: PubMed 28626237Zou J, Lai B, Zheng M, Chen Q, Jiang S, Song A, Huang Z, Shi P, Tu X, Wang D, Lu L, Lin Z, Gao X. CD4+ T cells memorize obesity and promote weight regain. Cell Mol Immunol. 2018 Jun;15(6):630-639. doi: 10.1038/cmi.2017.36. Epub 2017 Jun 19.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha lipoic acid (plus full hospitalization) in people with Obesity and Obesity, Abdominal, run by Fauqué at 1 site in France.
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 1 inclusion and 3 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 24 Jun 2020. 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 France. 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. Some participants in this study may receive a placebo. 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?
Variation in the prevalence of regulatory T cells from Peripheral Blood Mononuclear Cells (PBMCs) drawn from whole blood at the beginning (T0), mid-course (T4) and the end of the course (T8). (time frame: Through study completion, an average of 2 months). The study lists 3 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 NCT04436419, which also lists 10 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 24 Jun 2020.