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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| University of Aarhus | OTHER |
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The purpose of the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes.
People with type 2 diabetes have been shown to exhibit an altered composition of the gut microbiota, including a reduced abundance of butyrate-producing bacteria. Although the underlying mechanisms are not fully elucidated, alterations in gut microbiota composition may be important in the pathogenesis of type 2 diabetes and in metabolic regulation. Fecal microbiota transplantation (FMT) from lean donors has been shown to transiently improve insulin sensitivity and increase the abundance of butyrate-producing bacteria in individuals with metabolic syndrome.
A double-blinded, randomized, placebo-controlled trial will be conducted to investigate the effects of FMT on glycaemic metabolism and gut microbiota composition in individuals with type 2 diabetes. A total of 16 participants will be randomly assigned to one of two groups, receiving either FMT or placebo.
Glycaemic metabolism will be assessed at baseline and again at week 7 post-intervention using three complementary measures: the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), an oral glucose tolerance test (OGTT) for the Matsuda index, and continuous glucose monitoring (CGM). In addition, stool samples will be collected before and after the intervention to evaluate changes in gut microbiota composition following FMT, for example using 16S rRNA gene sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation | Experimental | The participants will receive two rounds of FMT with two weeks between each treatment. |
|
| Placebo | Placebo Comparator | Placebo capsules visually identical to FMT capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbial Transplantation | Other | The capsules consists of approximately 50 grams of donor feces. This is cryopreserved, homogenized and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 25 capsules. The fecal material is obtained from healthy donors, recruited from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive. Further, the donors lipid status and HbA1c is screened, ensuring only metabolically healthy donors are included. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Insulin sensitivity assessed by the Matsuda index, calculated from plasma glucose (in mmol/L) and serum insulin(in pmol/L) concentrations measured repeatedly during a standardized oral glucose tolerance test at baseline and after 7 weeks. | At baseline and at week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-in-range | Percentage of time with interstitial glucose values between 3.9 and 10.0 mmol/L, derived from continuous glucose monitoring data collected over a 10-day period at baseline and during the final two weeks of the intervention. | At baseline and at week 7 |
| Hemoglobin A1c |
| Measure | Description | Time Frame |
|---|---|---|
| LEAP-2/ghrelin | LEAP-2/ghrelin (arbitrary units, with LEAP-2 and ghrelin in ng/ml) | At baseline and at week 7 |
| GLP-1 | glukagonlike peptide-1 (in pmol/l) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Diagnostics Center, Regional Hospital Central Jutland (HEM) | Viborg | 8800 | Denmark |
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| Label | URL |
|---|---|
| Centre for Faecal Microbiota Transplantation - CEFTA | View source |
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IPD will be shared upon reasonable request to the corresponding author. Data will be de-identified where possible and made available to qualified researchers for scientific purposes. Due to the small sample size and risk of re-identification, data will not be deposited in a public repository
Data will be available beginning after publication of the primary study results and will remain available for a reasonable period thereafter, subject to continued data governance and ethical approval.
Access to IPD and supporting information will be granted to qualified researchers with a scientifically sound research proposal. Requests will be reviewed by the study investigators. Approved users will receive access to de-identified data relevant to the approved analysis, following execution of a data use agreement. Data will be shared via secure data transfer. Due to the small sample size, full datasets will not be made publicly available.
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|
| Placebo | Other | The placebo products consists of the same capsules as FMT. The content of the capsules is produced from a suspension of glycerol, saline and food coloring. The number of placebo capsules will correspond to the amount of FMT capsules. The placebo capsules will be identical in visual appearance. |
|
|
Hemoglobin A1c in plasma (in mmol/mol) |
| At baseline and at week 7 |
| Glucose management indicator | Glucose management indicator (GMI) calculated from mean interstitial glucose values derived from continuous glucose monitoring data collected over a 10-day period at baseline and during the final two weeks of the intervention. | At baseline and at week 7 |
| Body mass index | Weight (in kilograms), height (in meters) for calculation of BMI | At baseline and at week 7 |
| Waist circumference | Waist circumference(in centimeters) | At baseline and at week 7 |
| Microbiome analysis | Fecal samples will be collected and analyzed to characterize the gut microbiome and its changes in response to the intervention. Analyses may include 16S rRNA gene sequencing and/or other molecular or biochemical methods to assess microbial composition, diversity, and selected functional features. The specific analytical methods will be defined prior to analysis. | At baseline and at week 7 |
| At baseline and at week 7 |
| Interleukin 1-beta | IL1B measured with Multiplex (in pg/ml) | At baseline and at week 7 |
| Triglycerides | Measurements of serum triglycerides (in mmol/L) | At baseline and at week 7 |
| C-reactive protein | C-reactive protein (mg/L)) | At baseline and at week 7 |
| Remnant cholesterol | Remnant is calculated from Total, LDL, and HDL-cholesterol (all in mmol/L) | At baseline and at week 7 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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