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Trial record 48 of 146 for:    epilepsy AND Bethesda

Treatment of Type 2 Diabetes With Ketogenic Diet

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ClinicalTrials.gov Identifier: NCT03652649
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC

Tracking Information
First Submitted Date  ICMJE July 5, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
Type 2 diabetes remission [ Time Frame: 6 months (study duration) ]
Defined as normal fasting blood glucose (<126), normal HbA1C (<6.4%), and no diabetic medications
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • Change from baseline in glucose blood level in patients with type 2 DM in 6 months. [ Time Frame: 6 months (study duration) ]
    Defined as normal fasting blood glucose (<126), normal HbA1C (<6.4%), and no diabetic medications
  • Percentage of diabetic medication load reduction [ Time Frame: 6 months (study duration) ]
    Change in diabetic medication load
  • Change from baseline in HbA1C in patients with type 2 DM in 6 months. [ Time Frame: 0, 3 and 6 months treatment duration ]
    HbA1C
  • Adverse events [ Time Frame: 6 months (study duration) ]
    Adverse events occurrence
  • Fasting serum insulin [ Time Frame: 0, 3 and 6 months treatment duration ]
    Change in fasting serum insulin value
  • BMI [ Time Frame: Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change BMI from baseline
  • Weight [ Time Frame: Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change weight from baseline
  • Waist circumference [ Time Frame: Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change waist circumference from baseline
  • Blood pressure [ Time Frame: Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change of systolic and diastolic blood pressures from baseline
  • Urine ketone levels [ Time Frame: Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Urine ketone levels evaluation
  • Fasting leptin levels [ Time Frame: 0, 3 and 6 months treatment duration ]
    Fasting leptin levels evaluation
  • Fasting lipid levels [ Time Frame: 0, 3 and 6 months treatment duration ]
    Fasting lipid levels evaluation
  • Hunger scale scores [ Time Frame: Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Likert scale (range: extremely hungry to extremely full) which will be administered at each visit.The best outcome is 5=satisfied.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Type 2 Diabetes With Ketogenic Diet
Official Title  ICMJE Evaluation of Efficacy and Safety of Ketogenic Complete Meal Replacement as Treatment of Obesity-related Type 2 Diabetes Mellitus
Brief Summary The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) complete meal replacement treatment of obesity-related Type 2 diabetes mellitus (T2DM) and of obesity in patients with obesity and T2DM. This will be an open-label single arm study evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet.
Detailed Description

The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) complete meal replacement treatment of obesity-related Type 2 diabetes mellitus (T2DM) and of obesity in patients with obesity and T2DM. This will be an open-label single arm study evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet.

Treatment will consist of KD complete meal replacement with 3:1 [fat]: [protein + carbohydrate] weight ratio, and with 1600 kcal restriction. It will consist of pre-made meals, including breakfast, lunch, dinner and two snacks, one each between breakfast and lunch and lunch and dinner. Meals will be made according to supplied recipes (Anemone, LLC.) with a 3-week long meal plan consisting of different recipes for the 3 meals and 2 snacks different for each day of the 3-week cycle, with repeating cycles. All KD-treated participants will receive the same meal plan. Meals will be prepared uniformly by one facility and will be delivered to participants frozen once a week in packages subdivided into individual days with each day's package containing 5 separately packaged meals. Participants will be given a list of allowed 0 calories drinks and will consume no non-allowed beverages. Reductions to oral glycemic medications will occur at the start of the diet.

Participants will be evaluated in face-to-face visit during weeks 1, 2 and 4 of the study, then monthly (see Table 1, visit schedule). Evaluations will include weight, BMI, BP, waist circumference, adverse events and treatment compliance. Participants will check their blood glucose levels 3x/day, including am fasting, mid-day and evening 2 hours post-prandial, and urine for ketones levels with Ketostix (Bayer AG, IN, U.S.A.) 2x/day. They will record results in a glucose and ketone level diary which will be reviewed at each visit. Laboratory evaluations will include 8 am serum fasting glucose, insulin levels, C-peptide and lipid panel, HbA1C, serum beta-hydroxybutyrate (BOH), leptin levels, C-reactive protein (CRP), complete blood count (CBC), basic metabolic profile (BMP), renal and liver functions tests (LFTs), and uric acid. Laboratory evaluations will be obtained once at baseline prior to treatment initiation, at 3 and 6 months after treatment initiation. Hunger will be evaluated with a 7-point Likert scale (range: extremely hungry to extremely full) which will be administered at each visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type2 Diabetes Mellitus
  • Obesity
Intervention  ICMJE Other: 3:1 ratio Ketogenic diet
Type 2 Diabetic subjects with BMI greater than or equal to 30 are started on 3:1 ratio ketogenic complete meal replacement program and weight loss and glycemic control is tracked over 6 month intervention period
Other Name: Classic Ketogenic Diet
Study Arms  ICMJE Experimental: 3:1 Ketogenic Complete Meal Replacement
Evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day complete meal replacement ketogenic diet
Intervention: Other: 3:1 ratio Ketogenic diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-70
  2. Ability and willingness to sign informed consent form.
  3. T2D with BMI ≥ 30 kg/m2
  4. Stable hypoglycemic medications for at least 2 months

Exclusion Criteria:

  1. History of bariatric surgery ≤ 2 years prior to enrollment.
  2. 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.
  3. History of uncontrolled hyperlipidemia
  4. Change in the dose or type of hypoglycemic treatment within 1 month prior to enrollment.
  5. Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
  6. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
  7. History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
  8. Pregnancy
  9. Use of any investigational drugs within 3 months of enrollment.
  10. Inability or unwillingness of subject to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ivana Tyrlikova 3015309744 tyrlikovai@epilepsydc.com
Contact: Lenka Goldman 3015309744
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03652649
Other Study ID Numbers  ICMJE maes 009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC
Study Sponsor  ICMJE Mid-Atlantic Epilepsy and Sleep Center, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pavel Klein, M.B,B.Chir. Mid-Atlantic Epilepsy and Sleep Center
PRS Account Mid-Atlantic Epilepsy and Sleep Center, LLC
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP