- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03862521
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.
Participants will be admitted to the Clinical Research Center at baseline and 3 months. Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their insulin infusion rate through their insulin pump. Plasma glucose, catecholamines (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height and weight z-score before and after the 6 months of diet intervention. Change in growth velocity will also be assessed. During the study, participants not already using continuous glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects will also be monitoring serum ketones at home regularly.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria
- Prepubertal children 2 to <12 years old (i.e., before 12th birthday)
- Type 1 diabetes for at least 6 months
- Patients must be using insulin pump therapy
- Not presently on low carbohydrate diet
Exclusion criteria
- On low or very low carbohydrate diet
- History of endocrine or metabolic disorder that could affect counter-regulation (well-controlled hypothyroidism is acceptable if on stable dose of l-thyroxine for ≥3 months)
- History of metabolic disorder affection lipid metabolism
- Severe hypoglycemic event in past 3 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Low carbohydrate diet group
Low carb diet, carbohydrates make up 30-40% of total daily calories.
|
Low carbohydrate diet
|
Eksperimentel: Very low carbohydrate diet
Very low carb diet, carbohydrates make up 20-29% of total daily calories.
|
Very low carbohydrate diet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia
Tidsramme: Baseline to 3 months
|
Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia.
|
Baseline to 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in height in centimeters from baseline to 6 months
Tidsramme: Baseline to 6 months
|
Change in height in centimeters from baseline to 6 months
|
Baseline to 6 months
|
Change in weight in kilograms from baseline to 6 months
Tidsramme: Baseline to 6 months
|
Change in weight in kilograms from baseline to 6 months
|
Baseline to 6 months
|
Change in body composition from baseline to 6 months
Tidsramme: Baseline to 6 months
|
Change in percent body fat using DXA scan from baseline to 6 months
|
Baseline to 6 months
|
Change in A1c from baseline to 3 and 6 months
Tidsramme: Change from baseline to 3 and 6 months
|
Change in A1c over the length of the study
|
Change from baseline to 3 and 6 months
|
Change in lipid profile from baseline to 6 months
Tidsramme: Baseline to 6 months
|
Change in lipid profile from baseline to 6 months
|
Baseline to 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Larry A Fox, MD, Nemours Children's Health
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LowCHOT1D
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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