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Trial · NCT02069197

Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea

NCT02069197, Phase 2, Unknown, Mid-Atlantic Epilepsy and Sleep Center, LLC

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea. Trials, record NCT02069197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02069197

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
NCT number
NCT02069197
Status
Unknown
Phases
Phase 2
Enrollment
150 participants, estimated
Lead sponsor
Mid-Atlantic Epilepsy and Sleep Center, LLC
Conditions
Obesity, Diabetes, Obstructive Sleep Apnea
Interventions
Ketogenic diet, Orlistat, Standardized diet
First posted
2014-02-24
Last updated
2018-08-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange of body mass index from baseline in 9 months period9 monthsThe change of weight and the BMI(body mass index) will be calculated.
SecondaryChange from baseline in glucose blood level in patients with diabetes mellitus in 9 months.9 monthsHbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels
SecondaryChange of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity9 monthsFor participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index. Level of alertness will be evaluated with Epworth Sleepiness Scale.
SecondaryTo evaluate safety of ketogenic diet as a treatment of obesity.9 monthsEvaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02069197

GET https://conductscience.org/api/trials/v1/NCT02069197/registered