ObesityPhase 2KGDobesityNCT02069197
Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
A Phase 2 study testing Ketogenic diet, Orlistat and Standardized diet in people with Obesity and Diabetes, run by Mid-Atlantic Epilepsy and Sleep Center, LLC at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Diabetes, Obstructive Sleep Apnea
- What is being tested?
- Ketogenic diet, Orlistat and Standardized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2020
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70
- ability and willingness to signed informed consent form
- BMI more than 30kg/m2, with type 2 DM and/or OSA
- For diabetic participants, stable hypoglycemic medications for at least 2 months
- For participants with OSA, previously documented polysomnogram with apnea/hypopnea index (AHI)>15/h.
Who cannot join
- BMI change of +/- 3.0 kg/m2 of baseline BMI within past 12 months.
- History of bariatric surgery ≤ 3 years prior to enrollment.
- Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer.
- History of uncontrolled hyperlipidemia
- For participants with DM, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment.
- Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
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- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
- History of hyperthyroidism
- History of glaucoma
- History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
- Pregnancy
- Use of any investigational drugs within 3 months of enrollment.
- Inability or unwillingness of subject to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mid-Atlantic Epilepsy and Sleep Center, LLC
Bethesda, Maryland, 20817
Ivana Tyrlikova, MD, 301-530-9744, tyrlikovai@epilepsydc.com
Arcady Barber, MSCN, 301-530-9744, barbera@epilepsydc.com
About this study
Official title: Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).
Read the detailed description
The study sample will be randomized into three treatment arms, KD (Group A, n=50), Orlistat 120 mg TID (Group B, n=50) and dietary and lifestyle counseling (Group C, n=50) in a 1:1:1 ratio. Each arm will include 100% participants with obesity and co-morbid type 2 DM and 50% participants with co-morbid OSA. Randomization will be stratified for diabetic status.
- Conditions
- Obesity, Diabetes, Obstructive Sleep Apnea
- Being tested
- Ketogenic diet, Orlistat, Standardized diet
- Keywords
- ketogenic diet, obesity, diabetes, obstructive sleep apnea
- Medical subject headings
- Obesity, Diabetes Mellitus, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
Also called high fat, low protein, low carbohydrate diet
ketogenic diet will consist of 3:1[fat]:[protein+carbohydrate]weight ratio with 1600 kcal restriction. Diet will last 9 months.
OrlistatDrug
Also called tetrahydrolipstatin
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Standardized dietOther
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet, lifestyle counseling | Active comparator | ketogenic diet consisted of 3:1[fat]:[protein+carbohydrate] weight ratio with 1600kcal restriction. Receives: Other: Ketogenic diet |
| Orlistat, Lifestyle counseling | Active comparator | Orlistat 120 mg TID, standardized diet and lifestyle-modification counseling based on the LEARN (Life, Exercise, Attitudes, Relationships,and Nutrition) program with recommended caloric goal of 1600 kcal/day. Receives: Drug: Orlistat |
| Standartized diet, Lifestyle counseling | Active comparator | Standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day. Receives: Other: Standardized diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body mass index from baseline in 9 months period
The change of weight and the BMI(body mass index) will be calculated.
Measured: 9 months
Secondary outcomes (3)
Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
HbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels
Measured: 9 months
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
For participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index.
Level of alertness will be evaluated with Epworth Sleepiness Scale.
Measured: 9 months
To evaluate safety of ketogenic diet as a treatment of obesity.
Evaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC
- Investigators
- Pavel Klein, M.D., Principal investigator, Mid-Atlantic Epilepsy and Sleep center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069197
- Sponsor's protocol ID
- maes 004
- Acronym
- KGDobesity
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2013
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT02069197
- Acronym / sponsor ID
- KGDobesity / maes 004
- Conditions
- Obesity, Diabetes, Obstructive Sleep Apnea
- Keywords
- ketogenic diet, obesity, diabetes, obstructive sleep apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLCUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 24 Feb 2014 (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.
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).
Detailed description
The study sample will be randomized into three treatment arms, KD (Group A, n=50), Orlistat 120 mg TID (Group B, n=50) and dietary and lifestyle counseling (Group C, n=50) in a 1:1:1 ratio. Each arm will include 100% participants with obesity and co-morbid type 2 DM and 50% participants with co-morbid OSA. Randomization will be stratified for diabetic status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet, lifestyle counseling | Active comparator | Other: Ketogenic dietketogenic diet consisted of 3:1[fat]:[protein+carbohydrate] weight ratio with 1600kcal restriction. |
| Orlistat, Lifestyle counseling | Active comparator | Drug: OrlistatOrlistat 120 mg TID, standardized diet and lifestyle-modification counseling based on the LEARN (Life, Exercise, Attitudes, Relationships,and Nutrition) program with recommended caloric goal of 1600 kcal/day. |
| Standartized diet, Lifestyle counseling | Active comparator | Other: Standardized dietStandardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-70
- ability and willingness to signed informed consent form
- BMI more than 30kg/m2, with type 2 DM and/or OSA
- For diabetic participants, stable hypoglycemic medications for at least 2 months
- For participants with OSA, previously documented polysomnogram with apnea/hypopnea index (AHI)>15/h.
Key exclusion criteria (13 listed)
- BMI change of +/- 3.0 kg/m2 of baseline BMI within past 12 months.
- History of bariatric surgery ≤ 3 years prior to enrollment.
- Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer.
- History of uncontrolled hyperlipidemia
- For participants with DM, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment.
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 |
|---|---|---|
| Ketogenic dietAlso: high fat, low protein, low carbohydrate dietketogenic diet will consist of 3:1[fat]:[protein+carbohydrate]weight ratio with 1600 kcal restriction. Diet will last 9 months. | Other | Ketogenic diet, lifestyle counseling |
| OrlistatAlso: tetrahydrolipstatinOrlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day. | Drug | Orlistat, Lifestyle counseling |
| Standardized dietStandardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day. | Other | Standartized diet, Lifestyle counseling |
Primary outcome
Change of body mass index from baseline in 9 months period
Time frame: 9 months
The change of weight and the BMI(body mass index) will be calculated.
3 secondary outcomes
Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
Time frame: 9 months
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
Time frame: 9 months
To evaluate safety of ketogenic diet as a treatment of obesity.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- 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.
Pavel Klein, M.D. principal investigator
Mid-Atlantic Epilepsy and Sleep center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketogenic diet, Orlistat and Standardized diet in people with Obesity and Diabetes, run by Mid-Atlantic Epilepsy and Sleep Center, LLC at 1 site in United States.
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 5 inclusion and 13 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 17 Aug 2018. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ivana Tyrlikova, MD (301-530-9744, tyrlikovai@epilepsydc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body mass index from baseline in 9 months period (time frame: 9 months). 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 Aug 2018.