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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK129799 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with overweight and obesity as well as potential mechanisms to modify disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison of microbiome by BMI Category | No Intervention | The gut microbiome and metabolites of 42 lean and 42 overweight/obese youth with type 1 diabetes will be evaluated cross-sectionally. | |
| Metformin | Experimental | This is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin is an oral medication that improves insulin sensitivity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes | cross sectional comparison of stool microbiome using metagenomic sequencing data | Baseline |
| Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes | The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry | Baseline |
| Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes | The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry | Baseline |
| Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin | longitudinal comparison before and after taking metformin for 6 months, stool samples will be collected at baseline, 3 months and 6 months and sequenced for microbiome profile using metagenomic sequencing | Baseline, Month 3, and Month 6 |
| Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin | The investigators will measure and compare the stool and serum metabolites (short chain fatty acids and secondary bile acids) before, during and after 6 months of daily metformin therapy using mass spectrometry | Baseline, Month 3, and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in measures of C-peptide as a measure of beta cell health in lean and overweight/obeseT1D youth | The investigators will measure serum C-peptide to calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heba M Ismail | Contact | 317-274-2114 | heismail@iu.edu | |
| HI Team | Contact | 317-274-2114 | hiteam@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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The investigators will examine the differences in the gut microbiome between lean and overweight/obese youth with type 1 diabetes and then enroll the overweight/obese youth with type 1 diabetes into the clinical trial to receive metformin as an intervention.
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| Differences in measures Proinsulin as a measure of beta cell health in lean and overweight/obeseT1D youth |
The investigators will measure serum proinsulin and calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth. |
| Baseline |
| Differences in measures of insulin sensitivity in lean and overweight/obese T1D youth | Insulin sensitivity will be assessed in individuals using the estimated insulin sensitivity score (eIS), which is based on waist circumference (cm), HbA1c (%) and triglycerides (mg/dl) | Baseline |
| Changes in measures of C-peptide as a measure of beta cell health in overweight/obese T1D youth in response to metformin | Serum C-peptide will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy | Baseline, Month 3, and Month 6 |
| Changes in measures of proinsulin as a measure of beta cell health in overweight/obese T1D youth in response to metformin | Serum proinsulin will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy | Baseline, Month 3, and Month 6 |
| Changes in measures of insulin sensitivity in overweight/obese T1D youth in response to metformin | Estimated insulin sensitivity score will be used to assess response metformin therapy | Baseline, Month 3, and Month 6 |
| Changes in measures of beta cell function using a timed mixed meal tolerance test | Participants in the metformin trial will undergo a standard 2-hour mixed meal tolerance test at baseline and after 6 months of oral metformin therapy | Baseline and Month 6 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |