Treatment of Type 2 Diabetes With Ketogenic Diet

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

Tracking Information

• First Submitted Date: July 5, 2018
• First Posted Date: August 29, 2018
• Last Update Posted Date: August 29, 2018
• Actual Study Start Date: November 1, 2017
• Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Type 2 Diabetes With Ketogenic Diet
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Type2 Diabetes Mellitus
• Obesity

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 28, 2018): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2020
• Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ivana Tyrlikova; 3015309744; tyrlikovai@epilepsydc.com

Contact: Lenka Goldman; 3015309744

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03652649
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC
• Study Sponsor: Mid-Atlantic Epilepsy and Sleep Center, LLC
• Collaborators: Not Provided

Investigators

• 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