Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes
Overview
- Phase
- Phase 3
- Intervention
- Acetylated and Butyrylated High Amylose Maize Starch
- Conditions
- Type 1 Diabetes
- Sponsor
- Indiana University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change in the Gut Microbiome Profile
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on the gut microbiome profile, glycemia and β-cell function in humans with T1D.
Detailed Description
This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16 years with recently diagnosed type 1 diabetes. Approximately 12 participants will be randomized first to take the supplement or follow a diabetic diet for 4 weeks and then cross-over after a 4 week washout period. The primary objective is to determine the effect of using the prebiotic on the gut microbiome profile in youth with T1D. The secondary objectives are to determine the effect of using the prebiotic on SCFA production, glycemia and β-cell health and function. Exploratory outcomes include changes in MAIT cells.
Investigators
Heba M. Ismail
Assistant Professor of Pediatrics
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Be between 11-17 years of age
- •Willing to consume HAMS-AB and follow a diabetic diet
- •Diagnosed by American Diabetes Association criteria with T1D in the last 4-36 months
- •Random non-fasting C-peptide of 0.17nmol/ml or greater
- •Willing to use an effective form of contraception if sexually active
- •BMI\< 85% for age and sex
- •Positive for any one of the following diabetes-related autoantibodies that are tested clinically \[insulin autoantibody (if tested within 14 days of diagnosis), glutamic acid decarboxylase (GAD), insulinoma-associated protein-2 (IA-2), or Zinc transporter 8 autoantibodies (ZnT8)\].
Exclusion Criteria
- •Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, except for well-controlled hypothyroidism and mild asthma not requiring oral steroids.
- •Diabetes other than T1D (Known monogenic forms of diabetes, Type 2 diabetes)
- •Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
- •Psychiatric impairment or current use of anti-psychotic medication
- •Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
- •Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use an effective form of birth control or be abstinent during the study period (see below)
- •History of recurrent infections
- •History of on-going infections or antibiotic treatment within the past three months
- •History of immune compromise
- •Steroid intake (inhaled or oral)
Arms & Interventions
Supplement Intervention and Control Diet, then Control Diet Alone
This group will first consume the supplement daily for 4 weeks in addition to the diabetic diet then cross-over to follow the diabetic diet for 4 weeks.
Intervention: Acetylated and Butyrylated High Amylose Maize Starch
Outcomes
Primary Outcomes
Change in the Gut Microbiome Profile
Time Frame: before and after completion of each 4 week sequence
We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile. This measure was assesed using the absolute abundance of certain bacterial species of interest. The changes will be compared before and after each 4 week time period.
Secondary Outcomes
- Changes in the Short Chain Fatty Acid Levels in the Gut.(before and after completion of each 4 week sequence)
- Changes in Average Glucose(before and after completion of each 4 week sequence)
- C-peptide Levels (Changes in Beta Cell Health).(before and after completion of each 4 week sequence)