Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5M01RR000827 | U.S. NIH Grant/Contract | View source | |
| P30DK063491 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ruth L. Kirschstein National Research Service Award | FED |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Research Resources (NCRR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Obesity is a heightened state of inflammation in which production of cytokines and matrix metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes (DM2).
Design and Setting: 84 day (D84), double-blind, randomized, placebo (PL)-controlled clinical trial conducted in an academic tertiary care center.
Patients: Non-DM2 Controls (n=15); participants with DM2 receiving PL (n=13) or DOX (n=11).
Interventions: All participants were evaluated at day 1 (D1); those with DM2 were also evaluated at D84 after DOX 100mg twice daily or PL.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Experimental | Participants with DM2 receiving doxycycline 100mg BID |
|
| Placebo | Placebo Comparator | Pills prepared identical to doxycycline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | generic doxycycline 100mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| MMP Activity | MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. | Baseline (Day 1) |
| MMP Activity | MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84. | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| CRP | Measure of global inflammation. | Baseline (Day 1) |
| CRP | Measure of global inflammation. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen L Herbst, PhD, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Clinical trials Research Institute | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18606910 | Background | DeLano FA, Schmid-Schonbein GW. Proteinase activity and receptor cleavage: mechanism for insulin resistance in the spontaneously hypertensive rat. Hypertension. 2008 Aug;52(2):415-23. doi: 10.1161/HYPERTENSIONAHA.107.104356. Epub 2008 Jul 7. | |
| 23025537 | Result | Frankwich K, Tibble C, Torres-Gonzalez M, Bonner M, Lefkowitz R, Tyndall M, Schmid-Schonbein GW, Villarreal F, Heller M, Herbst K. Proof of Concept: Matrix metalloproteinase inhibitor decreases inflammation and improves muscle insulin sensitivity in people with type 2 diabetes. J Inflamm (Lond). 2012 Oct 1;9(1):35. doi: 10.1186/1476-9255-9-35. |
Not provided
Not provided
Not provided
The study included non-type 2 diabetics controls (n = 15), and type two diabetics subjects randomized to placebo (n = 13) or doxycycline 100 mg twice daily (n = 11).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline | Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily |
| FG001 | Placebo | Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline |
| FG002 | Control | non- type two diabetics to serve as a control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline | Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily |
| BG001 | Placebo | Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MMP Activity | MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. | Posted | Mean | Standard Error | uM 5-FAM/h-ug protein | Baseline (Day 1) |
|
Not provided
This information is being entered from a publication, since the Principal Investigator is no longer associated with the institution. The publication does not report on adverse events and so there is no way to report these numbers.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline | Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily |
Not provided
Not provided
This information is being entered from a publication, since the Principal Investigator is no longer associated with the institution. The publication does not report on adverse events and so there is no way to report these numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Louise Herbst | University of California, San Diego | 858-552-8585 | 7384 | kaherbst@gmail.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo comparator to doxycycline |
|
| Day 84 |
| BG002 | Control | Participants enrolled without type 2 diabetes to serve as a control |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | CRP | Measure of global inflammation. | Posted | Mean | Standard Error | microgram/ml | Baseline (Day 1) |
|
|
|
|
| Primary | MMP Activity | MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84. | Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84. | Posted | Mean | Standard Error | uM 5-FAM/h-ug protein | Day 84 |
|
|
|
| Secondary | CRP | Measure of global inflammation. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84. | Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84. | Posted | Mean | Standard Error | microgram/ml | Day 84 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |