Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Anxiety Disorders

Syndrome

Depression

Depressive Disorder

Mood Disorders

Polycystic Ovary Syndrome

Insulin Resistance

Vitamin D Deficiency

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Quality of Life

Hypoglycemic Agents

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Micronutrients

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Insulin

Insulin, Globin Zinc

Metformin

Vitamin D

Cholecalciferol

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Heather Huddleston, MD

Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.

This is a single center, open-label, randomized, pilot clinical trial. Women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin D insufficient are eligible. Subjects are randomly assigned to one of two interventions: Vitamin D versus metformin. Subjects are followed with questionnaires and a final wrap-up clinic visit with a physician. The study duration is 12 weeks.

Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial

Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial

BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.

STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score

Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated.

Reference ranges:

optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL

University of California, San Francisco

AE and SAE definition meet clinicaltrials.gov definitions

Investigators will carefully track serious adverse events and all of these events will be reported to the DSM at scheduled meetings. Grade 4 adverse events will be reported to the DSM within 24 hours of receipt by the Study Coordinator. Adverse events meeting IRB reporting criteria (adverse event that are definitely, probably, or possibly related to the research AND serious OR unexpected) will be reported within 5 working days.

Cholecalciferol 5,000 IU PO daily

Vitamin D: Oral medication daily

Vitamin D (Cholecalciferol)

Metformin 1000 mg PO bid

Metformin: Oral medication daily

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fasting blood insulin levels were assayed by Quest Diagnostics. Time point: Baseline, pre-intervention

Optimal Reference range:

Fasting 2.0-19.6 μIU/mL

Fasting Insulin

Fasting blood glucose levels were assayed by Quest Diagnostics. Time point: Baseline, pre-intervention

Optimal Reference range:

Fasting 65-99 mg/dL

Fasting Glucose

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnositcs.

Time point: Baseline, pre-intervention HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.

Fasting Insulin Resistance

Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Time period: baseline, pre-intervention

Reference ranges:

optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL

Vitamin D, 25 hydroxy

BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms.

Time period: baseline; pre-intervention

Score ranges:

{0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}.

Beck Depression Inventory (BDI-II)

STAI-S is a validated self-reported instrument of 20 questions. Time period: baseline, pre-intervention

Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms

State-Trait Anxiety Inventory Score (STAI-S)

Although 3 participants were assigned to Vitamin D, one dropped out just after enrollment and arm assigment and another dropped out after completing baseline time point measures, thus only one participant in the Vitamin D arm had data available for outcome measures analysis. Although 2 participants were assigned to Metformin, one dropped out just after enrollment and arm assignment, thus only one participant in the Metformin arm had data available for outcome measures analysis.

Feasibility of recruitment and participant completion determined to be too low to continue the study and the trial was terminated early, resulting in only 2 of the 5 enrolled participants completing the trial. This lead to only two subjects will full data and one subject with partial data being analyzed.

Heather Huddleston

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Depression from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 scores were available.

Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Insulin Resistance from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 serum insulin and glucose test results were available.

Changes From Baseline Week in Insulin Resistance Score at Week 12.

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for a Change in Anxiety scores from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 scores were available.

Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Vitamin D serum levels from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 serum Vitamin D test results were available.

Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.

Overall Study

Digestive System Diseases

Crohn Disease

Colitis

Colitis, Ulcerative

Intestinal Diseases

Inflammatory Bowel Diseases

Ulcer

Cognition Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Rectal Diseases

Gastroenteritis

Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital

Jérémie LEFEVRE, PU-PH

Harry SOKOL, PU-PH

Franck VERDONK, MD, PhD

Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored.

To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank.

A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient.

All samples will be anonymized.

* Intestinal surgical waste: Surgical samples will be rinsed in saline and aliquoted in dry tubes (minimum 5 aliquots) and lateral RNA (minimum 3 aliquots) and then frozen at -80°C
* Intestinal contents: They will be aliquoted (at least 5 aliquots) in dry tubes for freezing at -80°C
* blood samples (1 dry tube and 2 EDTA tubes of 7ml): centrifigation and aliquoting of serum and plasma, storage at -80°C
* whole blood samples (1 sodium heparin tube of 5ml) : stimulation and fixation with proteomic stabilizer, storage at -80°
* DNA ; Stored at -20°C
* stools: aliquoting and storage at -80°C

Digestive Biobank for Exploring Microbiota-host Interactions

identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

identify relations between plasma on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

identify relations between DNA on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

identify relations between faeces) on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

genetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications

genetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments

genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota

Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial	NCT03380091	PCOS Depression Vitamin D Defic... Insulin Resista...	Metformin Vitamin D	18 Years - 45 Years	University of California, San Francisco
Digestive Biobank for Exploring Microbiota-host Interactions	NCT05704413	Inflammatory Bo... Crohn Disease Ulcerative Coli... Colorectal Canc... Indeterminate C...		18 Years -	Assistance Publique - Hôpitaux de Paris
Digestive Biobank for Exploring Microbiota-host Interactions	NCT05704413	Inflammatory Bo... Crohn Disease Ulcerative Coli... Colorectal Canc... Indeterminate C...		18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for mood disorders