Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03710928
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Belinda Lennerz, Boston Children's Hospital

Brief Summary:

Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.

To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 7 study visits with fasting blood draws to evaluate diabetes control and metabolic health. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1C change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.


Condition or disease Intervention/treatment Phase
Type1diabetes Other: very low carbohydrate diet Other: standard carbohydrate diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial, 12-week feeding study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
Actual Study Start Date : January 3, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: very low carbohydrate diet
Dietary Intervention, food delivery
Other: very low carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement as needed with each meal to support digestive health, and a daily multi-vitamin, magnesium and omega-three supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.

The diet composition will be as follows: 5% carbohydrate, 70% fat, 20% protein.


Active Comparator: standard diet
Dietary Intervention, food delivery
Other: standard carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.

The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein.





Primary Outcome Measures :
  1. Hemoglobin A1C change [ Time Frame: 12 weeks - baseline ]
    HbA1C change from baseline at 12 weeks will be compared between the 2 interventions


Secondary Outcome Measures :
  1. total daily insulin dose [ Time Frame: week 0, 6 and 12 ]
    average daily insulin dose over 1 week will be calculated

  2. percent time spent in the glycemic target range of 70-140 mg/dl [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  3. percent time spent below the glycemic target of 70 mg/dl [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  4. percent time in hypoglycemia below 54 mg/dl [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  5. percent time spent above the glycemic target of 140 mg/dl [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  6. percent time spent in hyperglycemia [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  7. blood glucose average [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  8. blood glucose standard deviation [ Time Frame: week 0, 6 and 12 ]
    will be calculated from 1-week continuous glucose monitoring data

  9. Glycemic Variability Index, a measure for glycemic variability normalized to mean blood glucose level [ Time Frame: week 0, 6 and 12 ]
    will be calculated by dividing blood glucose standard deviation by blood glucose average

  10. Mean Amplitude of Glycemic Excursions (MAGE), a measure for postprandial glycemic variability [ Time Frame: week 0, 6 and 12 ]
    will be calculated by dividing blood glucose standard deviation by blood glucose average

  11. fasting total cholesterol [ Time Frame: week 0, 6 and 12 ]
    from venous blood

  12. fasting high density lipoprotein cholesterol [ Time Frame: week 0, 6 and 12 ]
    from venous blood

  13. fasting low density lipoprotein cholesterol [ Time Frame: week 0, 6 and 12 ]
    from venous blood

  14. fasting triglycerides [ Time Frame: week 0, 6 and 12 ]
    from venous blood

  15. fasting beta hydroxybutyrate [ Time Frame: weeks 0, 1, 2, 4, 6, 9, 12 ]
    from venous blood

  16. fasting bicarbonate [ Time Frame: weeks 0, 1, 2, 4, 6, 9, 12 ]
    from venous blood

  17. fasting high-sensitivity c-reactive protein [ Time Frame: week 0, 6 and 12 ]
    from venous blood

  18. Self-reported quality of life assessed per self-report by The Problem Areas in Diabetes Scale (PAID) [ Time Frame: week 0, 6 and 12 ]
    The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100.

  19. Becks Depression Inventory II (BDI II) [ Time Frame: week 0, 6 and 12 ]
    BDI-II is a 21-item self-report inventory that measures assesses for presence and severity of depression depressive symptoms. Each item is scored between 0-3. Item scores are added up to a total score (max. 63) and reported.

  20. Yale Food Addiction Scale 2.0 (YFAS 2.0) [ Time Frame: week 0, 6 and 12 ]
    Assesses indicators of addictive-like eating.The YFAS includes two scoring options: 1) a "symptom count" that reflects the number of addiction-like criteria endorsed and 2) a dichotomous "diagnosis" that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met. The diagnosis score will be calculated at baseline and used as an effect modifier. Symptom counts will be reported separately as a longitudinal measure.

  21. Highly Processed Food Withdrawal Scale (ProWS) [ Time Frame: Baseline, daily on days 1-7, then weekly; primary focus on change from baseline to day 7 ]
    Assesses withdrawal-type symptoms that may occur when individuals cut down on rewarding foods.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females with T1D for at least 1 year
  • Age 18 to 30 years
  • Tanner stage ≥ IV
  • BMI 18.5-30 kg/m2
  • Stable glycemic control (HbA1c 7-9%)
  • Use of a continuous glucose monitor (CGM)
  • Use of an insulin pump
  • Attendance of at least 3 diabetes care visits over the past 12 months

Exclusion Criteria:

  • Ketoacidosis or severe hypoglycemia with seizure or coma in the past year
  • Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
  • Following a weight-loss or otherwise restrictive diet
  • Use of medications or supplements other than insulin to control blood glucose
  • Vigorous exercise >2 hours on >3 days a week
  • History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
  • Major medical illness or use of medications that could interfere with metabolic or glycemic variables
  • Significant psychiatric illness or use of psychotropic medication
  • Smoking, use of recreational drugs, or excessive alcohol consumption
  • Pregnancy or breastfeeding
  • Irregular menses
  • Standard MRI exclusion criteria

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): NCT03710928


Contacts
Layout table for location contacts
Contact: Belinda Lennerz, MD PhD 8572183896 belinda.lennerz@childrens.harvard.edu
Contact: Svetlana Azova, MD 6173557476 svetlana.azova@childrens.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Belinda S Lennerz, MD PhD    857-218-3896    belinda.lennerz@childrens.harvard.edu   
Contact: Svetlana C Azova, MD    6179196675    svetlana.azova@childrens.harvard.edu   
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02446
Contact: Belinda Lennerz, MD PhD    857-218-3896 ext 6173557476    belinda.lennerz@childrens.harvard.edu   
Contact: David Ludwig    617 355 4878 ext 6173557476    david.ludwig@childrens.harvard.edu   
Sub-Investigator: David Ludwig, MD PhD         
Principal Investigator: Belinda Lennerz         
Sub-Investigator: Svetlana Azova         
Sponsors and Collaborators
Boston Children's Hospital
Publications:
Layout table for additonal information
Responsible Party: Belinda Lennerz, Principal Investigator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03710928    
Other Study ID Numbers: IRB-P00030039
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belinda Lennerz, Boston Children's Hospital:
very low carbohydrate diet
nutrition
ketogenic diet
ketosis
nutritional ketosis
metabolism
metabolic health
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases