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In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics arm | Experimental | Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214) |
|
| FMT arm | Experimental | Individuals who receive a FMT in the form of pills with fecal material from a healthy donor. |
|
| Control arm | Placebo Comparator | Individuals who receive a probiotics pill daily of placebo (milk powder) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus fermentum D3 | Dietary Supplement | Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HOMA-IR | Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5) | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut microbiota | Change from baseline in 16S rRNA amplicons after 3 months | Baseline, 12 weeks |
| Changes in glucose metabolism | Change from baseline in oral glucose tolerance test (OGTT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco J Tinahones, MD, PhD | Instituto de Investigacion Biomedica de Malaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| Fecal microbiota transplant (FMT) | Biological | Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material. |
|
| Placebo | Drug | Placebo in a white, gelatin capsule (orally), with powder milk |
|
| Baseline, 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |