PrediabetesNCT02683902
The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile
A study testing Active tDCS and Hypocaloric diet in people with Prediabetes and Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo associated with a reduced caloric diet on weight loss, glycemic control and regulators of hunger and satiety in overweight or obese subjects with different degrees of glucose tolerance, submitted to hypocaloric diet. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Obesity, Weight Loss
- What is being tested?
- Active tDCS and Hypocaloric diet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Aug 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of childbearing potential who are using medically approved birth control methods (eg hormonal contraceptives, intra uterine device (IUDs), barrier contraception) and who agree to use the same methods of contraception throughout the course of the study.
- BMI 25 ≥ 35 Kg/m2 at screening
- Stable weight for at least 12 weeks prior to screening
- Able and willing to provide written informed consent and to comply with the requirements of the study protocol
Who cannot join
- Pregnant or intend to become pregnant during the study period or who are currently breastfeeding.
- Women in perimenopause / menopause, or postmenopausal status, or who have had early menopause (under 40 years) or have had a hysterectomy or oophorectomy.
- Diagnosis or history of diabetes Mellitus type 1, diabetes resulting from pancreatic injury or secondary forms of diabetes, such as, for example, Cushing's syndrome and acromegaly.
- 3.1. Metabolic and acute complications of diabetes such as ketoacidosis and hyperosmolar coma within the past six months.
- Gastrointestinal disease clinically symptomatic including, among others, inflammatory bowel disease and/or malabsorption diseases.
- Have received nutritional counseling in the last six months by a nutritionist.
Show all 26Show fewer
- History of severe depression or other serious psychiatric comorbidities.
- History of gastric bypass, antrectomy or small bowel resection.
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Myocardial infarction (MI), coronary arteries bypass surgery, post-transplant cardiomyopathy or stroke in the last 6 months
- Any abnormality in clinical laboratory tests which might prevent safe participation in the study
- Diagnosed and / or treated tumor (except basal cell skin cancer, carcinoma in situ of the cervix or prostate cancer in situ) in the last five years.
- History of known hemoglobinopathy and chronic anemia.
- Donation of one unit (500 ml) of blood or more, significant blood loss equivalent to at least one unit of blood within the last 2 weeks or blood transfusion in the past 8 weeks.
- Treatment with any oral antidiabetic drugs and / or herbal preparations or medications that do not require a prescription and can affect glycemic control within 12 weeks prior to screening.
- Chronic treatment with oral or parenteral corticosteroids (> 7 consecutive days of treatment) within 4 weeks prior to screening.
- Treatment with weight loss agents (e.g., orlistat, sibutramine, topiramate, bupropion) in the last 12 weeks prior to screening.
- Treatment with mineral oil or fiber supplementation (e.g., Benefiber, Metamucil, among others).
- Treatment with lipid-lowering drugs which have not been kept on a stable dose for the past 8 weeks before screening.
- Treatment with thyroid replacement hormones which has not been kept on a stable dose for the past 12 weeks prior to screening.
- Use of drugs under investigation within 30 days or 5 half-lives (whichever is longer) before screening unless the guidelines of local health authorities require a longer period.
- Any of the following laboratory abnormalities identified in the screening by history and / or tests brought by the patient or that are part of this protocol, as described in section 4.3.4.6 of this project:
- 21.1. Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) > 3 times the upper limit of normal 21.2. Glomerular filtration rate estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ≤ 30 ml per min per 1,73 m2 21.3. Thyroid stimulating hormone (TSH) outside the normal range 21.4. Fasting triglycerides ≥ 400 mg / dL. 21.5. History of active substance abuse (including alcohol) within the past year
- Any condition or concomitant medical disorder, not provided for in other items which in the opinion of the investigator, probably:
- 22.1. Interfere with the patient's ability to complete the entire study period or participate in all activities of the study 22.2. Require during the study, administration of a treatment that may affect the interpretation of efficacy and safety data
- Patients potentially unreliable and those considered by the investigator as unsuitable for the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Fernando Gerchman, MD, +55 51 33598127, fgerchman@gmail.com
Carina de Araujo, RND, +55 51 33598127, carinanutr@hotmail.com
About this study
Official title: The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile: a Pilot, Double Blind, Randomized, Placebo-controlled Study
To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo associated with a reduced caloric diet on weight loss, glycemic control and regulators of hunger and satiety in overweight or obese subjects with different degrees of glucose tolerance, submitted to hypocaloric diet.
Read the detailed description
In order to assess whether tDCS treatment associated with a reduced caloric diet can improve weight loss, overweight or obese subjects will be recruited by advertisement on the web page of Porto Alegre Clinical Hospital, local newspaper and television, or referred by a doctor or nutritionist, from external to HCPA services. After screening and selection, patients will undergo a clinical, laboratory and nutritional evaluation. There will be a standard assessment protocol that includes: a complete clinical evaluation and socioeconomic status, assessment of physical activity, questionnaires of quality of life, sleep, depression and anxiety and body composition assessment.
In the laboratory evaluation the biochemistry exams include an oral glucose tolerance test (OGGT 75g), a meal tolerance test (MTT), serum glucose, Cholesterol, HDL-cholesterol, triglycerides, glycated hemoglobin and glycated albumin. The resting metabolic rate will be determine by indirect calorimetry. Besides, a 100-mm visual-analog scales will be used to measure a self-reported ratings of appetite, hunger, satiety and food craving.
Patients will also be prescribed a low caloric diet and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment. Moreover, they will do one tDCS session a day (active or sham stimulation as previous randomization) for 5 consecutive days, during these four weeks of treatment (20 sessions).
Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation in which a small current is applied to the scalp. This technique uses a weak safety current of 2 milliampere (mA) for 20 minutes which may increase (anodal tDCS) or decrease (cathodal tDCS) cortical excitability.
During all of tDCS sessions, a film with images of food that usually elicit craving will be presented and after the end of each session, visual analog scales will be applied to assess hunger, satiety and presence of food craving. Finally, attention and mood scales will be applied periodically in addition to a questionnaire of adverse effects and use of tDCS.
At the end of the 4-week diet and tDCS, all patients will be submitted to the same clinical, laboratory, nutrition and feeding behavior exams applied at baseline.
Finally, participants should come in 3 and 6 months after the end of the protocol for reassessment weight, body composition by bioelectrical impedance and answer questionnaires.
An interim analysis will be performed when 12 patients will be included.
- Conditions
- Prediabetes, Obesity, Weight Loss, Diabetes, Overweight
- Being tested
- Active tDCS, Hypocaloric diet, Sham tDCS
- Keywords
- prediabetes, tDCS, transcranial direct current stimulation, obesity, diabetes
- Medical subject headings
- Prediabetic State, Obesity, Weight Loss, Diabetes Mellitus, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Active
The anode electrode will be placed over F4 position and the cathode electrode over F3, right and left respectively (using EEG 10/20 system). The electric current will be ramped up until it reaches 2 milliampere (mA), and subjects will be stimulated for 20 min.
Hypocaloric dietBehavioural
Also called Diet
A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.
Sham tDCSDevice
Also called Placebo
The electrodes will be placed at the same positions as in active stimulation; however, the device will be turned off after 30 s of stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Diet | Active comparator | The participants will receive active tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment. Receives: Device: Active tDCS; Behavioral: Hypocaloric diet |
| Sham tDCS + Diet | Sham comparator | The participants will receive sham tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment. Receives: Behavioral: Hypocaloric diet; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
3% weight loss
Measured: 4 weeks
Secondary outcomes (7)
Changes in hormone levels after 4 week treatment
Changes in hormone levels of satiety, appetite and endocrine pancreas, such as insulin comparing baseline to end of intervention.
Measured: baseline and 4 weeks
Glycated Albumin
Reduction in fasting glycated albumin compared to baseline
Measured: baseline and 4 weeks
Fasting Plasma Glucose
Reduction in fasting plasma glucose from baseline
Measured: baseline and 4 weeks
Homeostatic Model Assessment (HOMA)
Insulin sensitivity index (HOMA-S) and Beta-cell dysfunction (HOMA-beta)
Measured: 4 weeks
Body Mass Index (BMI)
Number of patients who achieved a BMI reduction unit
Measured: 4 weeks
Intake of calories
Reduction or maintenance of the prescribed intake of calories during the 4-week intervention, in kcal/day, using a 3 days of food record, with food weighing.
Measured: 4 weeks
Weight, waist circumference and total body fat loss after 3 and 6 month of end of intervention
weight and waist circumference loss
Measured: 3 and 6 month after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Gerchman, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683902
- Sponsor's protocol ID
- 15-0119
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
PubMed 22029981Schur EA, Kleinhans NM, Goldberg J, Buchwald D, Schwartz MW, Maravilla K. Activation in brain energy regulation and reward centers by food cues varies with choice of visual stimulus. Int J Obes (Lond). 2009 Jun;33(6):653-61. doi: 10.1038/ijo.2009.56. Epub 2009 Apr 14.
PubMed 19365394Boggio PS, Zaghi S, Villani AB, Fecteau S, Pascual-Leone A, Fregni F. Modulation of risk-taking in marijuana users by transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC). Drug Alcohol Depend. 2010 Dec 1;112(3):220-5. doi: 10.1016/j.drugalcdep.2010.06.019. Epub 2010 Aug 21.
PubMed 20729009Fregni F, Orsati F, Pedrosa W, Fecteau S, Tome FA, Nitsche MA, Mecca T, Macedo EC, Pascual-Leone A, Boggio PS. Transcranial direct current stimulation of the prefrontal cortex modulates the desire for specific foods. Appetite. 2008 Jul;51(1):34-41. doi: 10.1016/j.appet.2007.09.016. Epub 2007 Dec 23.
PubMed 18243412Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23.
PubMed 21352881Montenegro RA, Okano AH, Cunha FA, Gurgel JL, Fontes EB, Farinatti PT. Prefrontal cortex transcranial direct current stimulation associated with aerobic exercise change aspects of appetite sensation in overweight adults. Appetite. 2012 Feb;58(1):333-8. doi: 10.1016/j.appet.2011.11.008. Epub 2011 Nov 12.
PubMed 22108669Kekic M, McClelland J, Campbell I, Nestler S, Rubia K, David AS, Schmidt U. The effects of prefrontal cortex transcranial direct current stimulation (tDCS) on food craving and temporal discounting in women with frequent food cravings. Appetite. 2014 Jul;78:55-62. doi: 10.1016/j.appet.2014.03.010. Epub 2014 Mar 20.
PubMed 24656950Lapenta OM, Sierve KD, de Macedo EC, Fregni F, Boggio PS. Transcranial direct current stimulation modulates ERP-indexed inhibitory control and reduces food consumption. Appetite. 2014 Dec;83:42-48. doi: 10.1016/j.appet.2014.08.005. Epub 2014 Aug 13.
PubMed 25128836Jauch-Chara K, Kistenmacher A, Herzog N, Schwarz M, Schweiger U, Oltmanns KM. Repetitive electric brain stimulation reduces food intake in humans. Am J Clin Nutr. 2014 Oct;100(4):1003-9. doi: 10.3945/ajcn.113.075481. Epub 2014 Aug 6.
PubMed 25099550Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PubMed 17452283Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PubMed 21320389Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PubMed 22037126Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
PubMed 16427357Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Bertolazi AN, Fagondes SC, Hoff LS, Pedro VD, Menna Barreto SS, Johns MW. Portuguese-language version of the Epworth sleepiness scale: validation for use in Brazil. J Bras Pneumol. 2009 Sep;35(9):877-83. doi: 10.1590/s1806-37132009000900009. English, Portuguese.
PubMed 19820814
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile: a Pilot, Double Blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02683902
- Acronym / sponsor ID
- 15-0119
- Conditions
- Prediabetes, Obesity, Weight Loss, Diabetes, Overweight
- Keywords
- prediabetes, tDCS, transcranial direct current stimulation, obesity, diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 17 Feb 2016 (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.
To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo associated with a reduced caloric diet on weight loss, glycemic control and regulators of hunger and satiety in overweight or obese subjects with different degrees of glucose tolerance, submitted to hypocaloric diet.
Detailed description
In order to assess whether tDCS treatment associated with a reduced caloric diet can improve weight loss, overweight or obese subjects will be recruited by advertisement on the web page of Porto Alegre Clinical Hospital, local newspaper and television, or referred by a doctor or nutritionist, from external to HCPA services. After screening and selection, patients will undergo a clinical, laboratory and nutritional evaluation. There will be a standard assessment protocol that includes: a complete clinical evaluation and socioeconomic status, assessment of physical activity, questionnaires of quality of life, sleep, depression and anxiety and body composition assessment.
In the laboratory evaluation the biochemistry exams include an oral glucose tolerance test (OGGT 75g), a meal tolerance test (MTT), serum glucose, Cholesterol, HDL-cholesterol, triglycerides, glycated hemoglobin and glycated albumin. The resting metabolic rate will be determine by indirect calorimetry. Besides, a 100-mm visual-analog scales will be used to measure a self-reported ratings of appetite, hunger, satiety and food craving.
Patients will also be prescribed a low caloric diet and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment. Moreover, they will do one tDCS session a day (active or sham stimulation as previous randomization) for 5 consecutive days, during these four weeks of treatment (20 sessions).
Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation in which a small current is applied to the scalp. This technique uses a weak safety current of 2 milliampere (mA) for 20 minutes which may increase (anodal tDCS) or decrease (cathodal tDCS) cortical excitability.
During all of tDCS sessions, a film with images of food that usually elicit craving will be presented and after the end of each session, visual analog scales will be applied to assess hunger, satiety and presence of food craving. Finally, attention and mood scales will be applied periodically in addition to a questionnaire of adverse effects and use of tDCS.
At the end of the 4-week diet and tDCS, all patients will be submitted to the same clinical, laboratory, nutrition and feeding behavior exams applied at baseline.
Finally, participants should come in 3 and 6 months after the end of the protocol for reassessment weight, body composition by bioelectrical impedance and answer questionnaires.
An interim analysis will be performed when 12 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Diet | Active comparator | Device: Active tDCS, Behavioral: Hypocaloric dietThe participants will receive active tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment. |
| Sham tDCS + Diet | Sham comparator | Behavioral: Hypocaloric diet, Device: Sham tDCSThe participants will receive sham tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women of childbearing potential who are using medically approved birth control methods (eg hormonal contraceptives, intra uterine device (IUDs), barrier contraception) and who agree to use the same methods of contraception throughout the course of the study.
- BMI 25 ≥ 35 Kg/m2 at screening
- Stable weight for at least 12 weeks prior to screening
- Able and willing to provide written informed consent and to comply with the requirements of the study protocol
Key exclusion criteria (26 listed)
- Pregnant or intend to become pregnant during the study period or who are currently breastfeeding.
- Women in perimenopause / menopause, or postmenopausal status, or who have had early menopause (under 40 years) or have had a hysterectomy or oophorectomy.
- Diagnosis or history of diabetes Mellitus type 1, diabetes resulting from pancreatic injury or secondary forms of diabetes, such as, for example, Cushing's syndrome and acromegaly.
- 3.1. Metabolic and acute complications of diabetes such as ketoacidosis and hyperosmolar coma within the past six months.
- Gastrointestinal disease clinically symptomatic including, among others, inflammatory bowel disease and/or malabsorption 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 |
|---|---|---|
| Active tDCSAlso: ActiveThe anode electrode will be placed over F4 position and the cathode electrode over F3, right and left respectively (using EEG 10/20 system). The electric current will be ramped up until it reaches 2 milliampere (mA), and subjects will be stimulated for 20 min. | Device | Active tDCS + Diet |
| Hypocaloric dietAlso: DietA hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment. | Behavioural | Active tDCS + Diet, Sham tDCS + Diet |
| Sham tDCSAlso: PlaceboThe electrodes will be placed at the same positions as in active stimulation; however, the device will be turned off after 30 s of stimulation. | Device | Sham tDCS + Diet |
Primary outcome
Weight loss
Time frame: 4 weeks
3% weight loss
7 secondary outcomes
Changes in hormone levels after 4 week treatment
Time frame: baseline and 4 weeks
Glycated Albumin
Time frame: baseline and 4 weeks
Fasting Plasma Glucose
Time frame: baseline and 4 weeks
Homeostatic Model Assessment (HOMA)
Time frame: 4 weeks
Body Mass Index (BMI)
Time frame: 4 weeks
Intake of calories
Time frame: 4 weeks
Weight, waist circumference and total body fat loss after 3 and 6 month of end of intervention
Time frame: 3 and 6 month after end of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 22029981Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
- Background: PubMed 19365394Schur EA, Kleinhans NM, Goldberg J, Buchwald D, Schwartz MW, Maravilla K. Activation in brain energy regulation and reward centers by food cues varies with choice of visual stimulus. Int J Obes (Lond). 2009 Jun;33(6):653-61. doi: 10.1038/ijo.2009.56. Epub 2009 Apr 14.
- Background: PubMed 20729009Boggio PS, Zaghi S, Villani AB, Fecteau S, Pascual-Leone A, Fregni F. Modulation of risk-taking in marijuana users by transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC). Drug Alcohol Depend. 2010 Dec 1;112(3):220-5. doi: 10.1016/j.drugalcdep.2010.06.019. Epub 2010 Aug 21.
- Background: PubMed 18243412Fregni F, Orsati F, Pedrosa W, Fecteau S, Tome FA, Nitsche MA, Mecca T, Macedo EC, Pascual-Leone A, Boggio PS. Transcranial direct current stimulation of the prefrontal cortex modulates the desire for specific foods. Appetite. 2008 Jul;51(1):34-41. doi: 10.1016/j.appet.2007.09.016. Epub 2007 Dec 23.
- Background: PubMed 21352881Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23.
- Background: PubMed 22108669Montenegro RA, Okano AH, Cunha FA, Gurgel JL, Fontes EB, Farinatti PT. Prefrontal cortex transcranial direct current stimulation associated with aerobic exercise change aspects of appetite sensation in overweight adults. Appetite. 2012 Feb;58(1):333-8. doi: 10.1016/j.appet.2011.11.008. Epub 2011 Nov 12.
- Background: PubMed 24656950Kekic M, McClelland J, Campbell I, Nestler S, Rubia K, David AS, Schmidt U. The effects of prefrontal cortex transcranial direct current stimulation (tDCS) on food craving and temporal discounting in women with frequent food cravings. Appetite. 2014 Jul;78:55-62. doi: 10.1016/j.appet.2014.03.010. Epub 2014 Mar 20.
- Background: PubMed 25128836Lapenta OM, Sierve KD, de Macedo EC, Fregni F, Boggio PS. Transcranial direct current stimulation modulates ERP-indexed inhibitory control and reduces food consumption. Appetite. 2014 Dec;83:42-48. doi: 10.1016/j.appet.2014.08.005. Epub 2014 Aug 13.
- Background: PubMed 25099550Jauch-Chara K, Kistenmacher A, Herzog N, Schwarz M, Schweiger U, Oltmanns KM. Repetitive electric brain stimulation reduces food intake in humans. Am J Clin Nutr. 2014 Oct;100(4):1003-9. doi: 10.3945/ajcn.113.075481. Epub 2014 Aug 6.
- Background: PubMed 17452283Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
- Background: PubMed 21320389Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
- Background: PubMed 22037126Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
- 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.
Fernando Gerchman, MD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and Hypocaloric diet in people with Prediabetes and Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 26 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: status not confirmed, as of the sponsor's last update on 8 Nov 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Gerchman, MD (+55 51 33598127, fgerchman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 4 weeks). 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 NCT02683902, which also lists 21 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 8 Nov 2017.