Treatment of Type 2 Diabetes With Ketogenic Diet

Obesity Clinical Trial

Official title:

Evaluation of Efficacy and Safety of Ketogenic Complete Meal Replacement as Treatment of Obesity-related Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03652649
• Other study ID #: maes 009
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2018
• Source: Mid-Atlantic Epilepsy and Sleep Center, LLC
• Contact: Ivana Tyrlikova
• Phone: 3015309744
• Email: tyrlikovai[@]epilepsydc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type2 Diabetes Mellitus

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

Locations

Country	Name	City	State
United States	Ivana Tyrlikova	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mid-Atlantic Epilepsy and Sleep Center, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 2 diabetes remission	Defined as normal fasting blood glucose (<126), normal HbA1C (<6.4%), and no diabetic medications	6 months (study duration)
Secondary	Change from baseline in glucose blood level in patients with type 2 DM in 6 months.	Defined as normal fasting blood glucose (<126), normal HbA1C (<6.4%), and no diabetic medications	6 months (study duration)
Secondary	Percentage of diabetic medication load reduction	Change in diabetic medication load	6 months (study duration)
Secondary	Change from baseline in HbA1C in patients with type 2 DM in 6 months.	HbA1C	0, 3 and 6 months treatment duration
Secondary	Adverse events	Adverse events occurrence	6 months (study duration)
Secondary	Fasting serum insulin	Change in fasting serum insulin value	0, 3 and 6 months treatment duration
Secondary	BMI	Change BMI from baseline	Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6
Secondary	Weight	Change weight from baseline	Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6
Secondary	Waist circumference	Change waist circumference from baseline	Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6
Secondary	Blood pressure	Change of systolic and diastolic blood pressures from baseline	Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6
Secondary	Urine ketone levels	Urine ketone levels evaluation	Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6
Secondary	Fasting leptin levels	Fasting leptin levels evaluation	0, 3 and 6 months treatment duration
Secondary	Fasting lipid levels	Fasting lipid levels evaluation	0, 3 and 6 months treatment duration
Secondary	Hunger scale scores	Likert scale (range: extremely hungry to extremely full) which will be administered at each visit.The best outcome is 5=satisfied.	Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6