patients with postural orthostatic tachycardia syndrome diagnosis.

Patients with Postural orthostatic tachycardia syndrome who has peripheral neuropathy

Whole blood will be retain for DNA extraction.

Postural Tachycardia Syndrome

Oral glucose tolerance test

Vanderbilt University Medical Center

Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome

POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AND GASTROINTESTINAL SYMPTOMS: Contribution of Gastrointestinal Peptides

The plasma levels of GI peptides (GLP-1, GLP-2, PPY, glucagon, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.

Gastric emptying time will be measured by acetaminophen absorption test after ingestion of 75 grams glucose.

The gastrointestinal symptoms will be evaluated by questionnaire after ingestion of 75 grams glucose.

Symptoms related to postural orthostatic tachycardia symptoms will be evaluated by specific questionnaire after ingestion of 75 grams glucose.

Cyndya Shibao

Assistant Professor

Sitagliptin 100mg once daily orally or 50mg once daily for participants with moderate kidney disease for 24 weeks and narrowband ultraviolet-B (NBUVB) phototherapy.
NBUVB light therapy is continued until the participants' psoriasis clears (<1% body surface area involved).

No additional treatment other than narrowband ultraviolet-B (NBUVB) phototherapy.
NBUVB light therapy is continued until the participants' psoriasis clears (<1% body surface area involved).

Psoriasis

Sitagliptin 100mg tablet once daily (or 50mg once daily for participants with moderate kidney disease) for twenty four weeks in patients due to undergo NBUVB light therapy.

Sitagliptin (Januvia)

A web-based randomization plan generator.

UCD Clinical Research Centre, St Vincent's University Hospital

Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP)

Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP): A Randomised Clinical Trial

Changes in serum concentrations of cytokines (C-reactive protein, interleukin-6 (IL-6), tumour necrosis factor alpha (TNFα) etc) Changes in serum concentrations of hormones (GLP-1, peptide YY (PYY) etc); and Changes in peripheral blood mononuclear cell expression of immune proteins (IL-6, TNFα, IL-10, IL-27 etc).

HADS: Hospital Anxiety and Depression Scale

HAQ8: Stanford Health Assessment Questionnaire 8-item disability scale

University College Dublin

Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.

Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.

Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
.

Sitagliptin

Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
.

Gliclazide

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Psoriasis area and severity index (PASI): the scale is an objective measure of psoriasis severity. The range for PASI is 0-72 with higher values indicating a worse outcome.

PASI

Psoriasis area and severity index (0-72), higher scores worse outcome

The Change in the Psoriasis Area and Severity Index (PASI) From Baseline to 16 Weeks in Psoriasis Patients With Type 2 Diabetes Treated With Sitagliptin Compared to Patients Treated With Gliclazide.

Dosage: Sitagliptin: 100mg daily, or 50mg daily for participants with moderate kidney disease Gliclazide: 80-320 mg daily.
Secondary outcomes: the number participants with adverse events.

The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks.

Dermatology life quality index (a skin related quality of life measure) (0-10), higher score worse outcome EQ-5D Euroqol 5 item quality of life index comprising 5 dimensions mobility, self-care, usual activities, pain, anxiety. An index can be derived from these 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state and minimum score indicating the worst health outcome -0.594.
HADS Hospital anxiety and depression scale 0-16 for anxiety and 0-16 for depression, higher score worse outcome HAQ-8 Stanford 8 item disability scale. Scoring is from 0 (without any difficulty) to 3 (unable to do). The 8 scores from the 8 sections are summed and divided by 8. The result is the disability index (range 0-3 with 25 possible values). A

The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.

Secondary outcomes:
d. number or participants who acheived a greater than 50% reduction in PASI from baseline (PASI-50); e. number of participants who achieved PASI-75 and PASI-90.

The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints.

High sensitivity C-reactive protein (range 0 - no maximum)

Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Sitagliptin: Week 0-16: Two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the double-blind phase.
Week 16-32: Then two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the open-label phase of the trial.

The Change in Levels of High Sensitivity C-reactive Protein From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.

Secondary outcomes:
The change in serum concentrations of the cytokines tumour necrosis factor alpha (TNFα) Range: 0-no maximum

The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Serum Cytokine Tumour Necrosis Factor Alpha.

Psoriasis area and severity index 0-72, higher score worse outcome

The Change in PASI From Baseline to 32 Weeks in Psoriasis Patients With Type 2 Diabetes Treated With Sitagliptin Compared to Patients Treated With Gliclazide.

The change in weight from baseline to 16 weeks measured in kg

The Change in Weight From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.

Interleukin 17 levels in skin (0-no maximum)

The Effect of Treatment With Sitagliptin and With Gliclazide From Baseline to 16 Weeks on the Change in Interleukin-17 Levels in the Skin (in a Sub-group of Participants Willing to Undergo Skin Biopsies).

The change in systolic blood pressure from baseline to 16 weeks measured in kg

The Change in Levels of Systolic Blood Pressure From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.

The change in glucose from baseline to 16 weeks

The Change in Levels of Serum Glucose From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.

The change in total cholesterol from baseline to 16 weeks

The Change in Levels of Total Cholesterol From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.

Secondary outcomes:
The change in serum concentrations of the cytokine interleukin-23 (IL-23) Range: 0-no maximum

The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-23.

Secondary outcomes:
The change in serum concentrations of the cytokine interleukin-17 (IL-17) Range: 0-no maximum

The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-17.

Secondary outcomes:
The change in serum concentrations of the adipokine leptin Range: 0-no maximum

The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Change in Serum Leptin From Baseline to 16 Weeks.

Dipeptidyl peptidase-4 levels levels in skin (0-no maximum)

The Effect of Treatment With Sitagliptin and With Gliclazide From Baseline to 16 Weeks on the Change in Dipeptidyl Peptidase-4 Levels in the Skin (in a Sub-group of Participants Willing to Undergo Skin Biopsies).

Overall Study

Dr Maeve Lynch

Type 2 Diabetes Mellitus

Week 0-16: Two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the double-blind phase.
Week 16-32: Then two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the open-label phase of the trial.

Double-blind phase (week 0-16):
One 80mg capsule once daily for 4 weeks. The if no severe hypoglycaemic episodes one 80mg capsule twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes two 80mg capsules twice daily for 8 weeks.

Week 0-16: Two tablets (or one tablet for those with moderate kidney disease) daily for 16 weeks during the double-blind phase.

Sitagliptin matched placebo

Double-blind phase (week 0-16):
One capsule daily for 4 weeks. Then if no severe hypoglycaemic episodes one capsule twice daily for 4 weeks. Then if no severe hypoglycaemic episodes two capsules twice daily for 8 weeks.

peptidase/fejfájás

Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome

Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP)

Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.

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