An interventional study of very low carbohydrate diet and standard carbohydrate diet in Type1diabetes, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Supportive care
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 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. 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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
For participants who undergo MRI:
Dietary Intervention, food delivery
Other: very low carbohydrate 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 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.
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.
Hemoglobin A1C change
HbA1C change from baseline at 12 weeks will be compared between the 2 interventions
Time frame: 12 weeks - baseline
total daily insulin dose
average daily insulin dose over 1 week will be calculated
Time frame: week 0 and 12
percent time spent in the glycemic target range of 70-140 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
percent time spent below the glycemic target of 70 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
percent time in hypoglycemia below 54 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
percent time spent above the glycemic target of 140 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
percent time spent in hyperglycemia
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
blood glucose average
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
blood glucose standard deviation
will be calculated from 1-week continuous glucose monitoring data
Time frame: week 0 and 12
Glycemic Variability Index, a measure for glycemic variability normalized to mean blood glucose level
will be calculated by dividing blood glucose standard deviation by blood glucose average
Time frame: week 0 and 12
Mean Amplitude of Glycemic Excursions (MAGE), a measure for postprandial glycemic variability
will be calculated by dividing blood glucose standard deviation by blood glucose average
Time frame: week 0 and 12
fasting total cholesterol
from venous blood
Time frame: week 0 and 12
fasting high density lipoprotein cholesterol
from venous blood
Time frame: week 0 and 12
fasting low density lipoprotein cholesterol
from venous blood
Time frame: week 0 and 12
fasting triglycerides
from venous blood
Time frame: week 0 and 12
fasting beta hydroxybutyrate
from venous blood and/or point-of-care testing
Time frame: weeks 0, 1, 2, 4, 6, 9, 12
fasting high-sensitivity c-reactive protein
from venous blood
Time frame: week 0 and 12
Self-reported quality of life assessed per self-report by The Problem Areas in Diabetes Scale (PAID)
The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100.
Time frame: week 0, 6, and 12
Becks Depression Inventory II (BDI II) less suicidality
BDI-II less suicidality is a 20-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. 60) and reported.
Time frame: week 0, 6, and 12
Yale Food Addiction Scale 2.0 (YFAS 2.0)
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.
Time frame: week 0, 6, and 12
Highly Processed Food Withdrawal Scale (ProWS)
Assesses withdrawal-type symptoms that may occur when individuals cut down on rewarding foods.
Time frame: Baseline, daily on days 1-7, then weekly; primary focus on change from baseline to day 7
Plan to share: Undecided
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