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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

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Obesity Other: 3:1 ratio Ketogenic diet Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Ketogenic Complete Meal Replacement as Treatment of Obesity-related Type 2 Diabetes Mellitus
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Percentage of diabetic medication load reduction [ Time Frame: 6 months (study duration) ]
    Change in diabetic medication load

  3. Change from baseline in HbA1C in patients with type 2 DM in 6 months. [ Time Frame: 0, 3 and 6 months treatment duration ]
    HbA1C

  4. Adverse events [ Time Frame: 6 months (study duration) ]
    Adverse events occurrence

  5. Fasting serum insulin [ Time Frame: 0, 3 and 6 months treatment duration ]
    Change in fasting serum insulin value

  6. BMI [ Time Frame: Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change BMI from baseline

  7. Weight [ Time Frame: Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change weight from baseline

  8. Waist circumference [ Time Frame: Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Change waist circumference from baseline

  9. 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

  10. Urine ketone levels [ Time Frame: Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6 ]
    Urine ketone levels evaluation

  11. Fasting leptin levels [ Time Frame: 0, 3 and 6 months treatment duration ]
    Fasting leptin levels evaluation

  12. Fasting lipid levels [ Time Frame: 0, 3 and 6 months treatment duration ]
    Fasting lipid levels evaluation

  13. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652649


Contacts
Contact: Ivana Tyrlikova 3015309744 tyrlikovai@epilepsydc.com
Contact: Lenka Goldman 3015309744

Locations
United States, Maryland
Ivana Tyrlikova Recruiting
Bethesda, Maryland, United States, 20817
Contact: Ivana Tyrlikova, MD    301-530-9744    tyrlikovai@epilepsydc.com   
Contact: Pavel Klein, MD    3015309744    kleinp@epilepsydc.com   
Principal Investigator: Pavel Klein, MD         
Sponsors and Collaborators
Mid-Atlantic Epilepsy and Sleep Center, LLC
Investigators
Principal Investigator: Pavel Klein, M.B,B.Chir. Mid-Atlantic Epilepsy and Sleep Center

Responsible Party: Pavel Klein, Principal Investigator, Mid-Atlantic Epilepsy and Sleep Center, LLC
ClinicalTrials.gov Identifier: NCT03652649     History of Changes
Other Study ID Numbers: maes 009
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC:
type 2 diabetes
diabetes
ketogenic diet
low carb diet
weight loss
obesity
diet treatment
nutrition
BMI

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms