Trial Outcomes & Findings for Morbidity in Newly Diagnosed type2 Diabetes in Adults (NCT NCT02002091)

NCT ID: NCT02002091

Last Updated: 2024-06-21

Results Overview

* Conventional ophtalmoscopy has been used to screen for diabetic retinopathy by an ophtalmologist at his office. * Retinal angiography was performed if indicated by the ophtalmologist

• Recruitment status: COMPLETED
• Target enrollment: 327 participants
• Primary outcome timeframe: At recruitment
• Results posted on: 2024-06-21

Participant Flow

327 patients aged from 40 to 70 years were seen from 2009 to 2013. The main investigator confirmed the diagnosis of type 2 diabetes. A secondary diabetes was excluded before definitive recruitment. When the diagnosis of type 2 diabetes is highly probable and ensure that it was newly diagnosed, we screened for all chronic complications.

Participant milestones

Measure	Complications' Assessment for Men 122 patients had a complete clinical examination, we realized an electrocardiogram, some biological exams for glycemic, hepatical, hematological and inflammatory status. We performed, in assessing macroangiopathy, an echocardiography, a vascular ultrasonography, a cardiac stress testing ( myocardial scintigraphy or stress electrocardiogram), a coronaroangiography if indicated and a cerebral scanner in case of suspicion of stroke. For the assessment of microangiopathy, we practiced a fundoscopy, a neurological examination to screen for peripheral neuropathy in all patients, we performed the Ewing tests for cardiac autonomic neuropathy , post voiding residual for diabetic cystopathy, a manocystometry if indicated and evaluated the renal status (ACR, creatininemia, uro-nephrological echography) in all patients.	Complications' Assessment for Women 205 patients had a complete clinical examination, we realized an electrocardiogram, some biological exams for glycemic, hepatical, hematological and inflammatory status. We performed, in assessing macroangiopathy, an echocardiography, a vascular ultrasonography, a cardiac stress testing (myocardial scintigraphy or stress electrocardiogram) to screen for ischemic myocardial, a coronaroangiography if indicated and a cerebral scanner in patients with suspected stroke. For the assessment of microangiopathy, we practiced a fundoscopy by an ophtalmologist, a neurological examination to screen for peripheral neuropathy, we performed the Ewing tests to screen for cardiac autonomic neuropathy, a post voiding residual to search for diabetic cystopathy, a manocystometry if indicated and evaluate the renal status (ACR, creatininemia, uro-nephrological echography) in all patients.
Screening STARTED	122	205
Screening COMPLETED	109	191
Screening NOT COMPLETED	13	14
One Year Follow up STARTED	109	191
One Year Follow up COMPLETED	109	191
One Year Follow up NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Complications' Assessment for Men 122 patients had a complete clinical examination, we realized an electrocardiogram, some biological exams for glycemic, hepatical, hematological and inflammatory status. We performed, in assessing macroangiopathy, an echocardiography, a vascular ultrasonography, a cardiac stress testing ( myocardial scintigraphy or stress electrocardiogram), a coronaroangiography if indicated and a cerebral scanner in case of suspicion of stroke. For the assessment of microangiopathy, we practiced a fundoscopy, a neurological examination to screen for peripheral neuropathy in all patients, we performed the Ewing tests for cardiac autonomic neuropathy , post voiding residual for diabetic cystopathy, a manocystometry if indicated and evaluated the renal status (ACR, creatininemia, uro-nephrological echography) in all patients.	Complications' Assessment for Women 205 patients had a complete clinical examination, we realized an electrocardiogram, some biological exams for glycemic, hepatical, hematological and inflammatory status. We performed, in assessing macroangiopathy, an echocardiography, a vascular ultrasonography, a cardiac stress testing (myocardial scintigraphy or stress electrocardiogram) to screen for ischemic myocardial, a coronaroangiography if indicated and a cerebral scanner in patients with suspected stroke. For the assessment of microangiopathy, we practiced a fundoscopy by an ophtalmologist, a neurological examination to screen for peripheral neuropathy, we performed the Ewing tests to screen for cardiac autonomic neuropathy, a post voiding residual to search for diabetic cystopathy, a manocystometry if indicated and evaluate the renal status (ACR, creatininemia, uro-nephrological echography) in all patients.
Screening Lost to Follow-up	10	12
Screening Death	3	2

Baseline Characteristics

Morbidity in Newly Diagnosed type2 Diabetes in Adults

Baseline characteristics by cohort

Measure	Men Population n=122 Participants Screening for all chronic complications were performed for men. A non specific multi interventional treatment is applied to patients, as lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin) treatment of comorbidity or complications of diabetes as soon as the patients are recruited.	Women Population n=205 Participants Screening for all chronic complications were performed for women. A non specific multi interventional treatment is applied to patients, as lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes as soon as the patients are recruited.	Total n=327 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 8.9 • n=5 Participants	53.7 years STANDARD_DEVIATION 8.4 • n=7 Participants	53.5 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	205 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	0 Participants n=7 Participants	122 Participants n=5 Participants
Region of Enrollment Algeria	122 participants n=5 Participants	205 participants n=7 Participants	327 participants n=5 Participants
history of family diabetes	84 participants n=5 Participants	138 participants n=7 Participants	222 participants n=5 Participants
history of family hypertension	69 participants n=5 Participants	133 participants n=7 Participants	202 participants n=5 Participants
waist circumference	98.1 cm STANDARD_DEVIATION 10.4 • n=5 Participants	99.3 cm STANDARD_DEVIATION 10.8 • n=7 Participants	98.9 cm STANDARD_DEVIATION 10.7 • n=5 Participants
BMI	26.6 kg/m² STANDARD_DEVIATION 4.9 • n=5 Participants	28.9 kg/m² STANDARD_DEVIATION 5.1 • n=7 Participants	28.0 kg/m² STANDARD_DEVIATION 5.2 • n=5 Participants
Systolic blood pressure	139.9 mm Hg STANDARD_DEVIATION 22.6 • n=5 Participants	141.9 mm Hg STANDARD_DEVIATION 23.9 • n=7 Participants	141.2 mm Hg STANDARD_DEVIATION 23.4 • n=5 Participants
Diastolic blood pressure	86.6 mm Hg STANDARD_DEVIATION 13.0 • n=5 Participants	85.3 mm Hg STANDARD_DEVIATION 10.9 • n=7 Participants	85.8 mm Hg STANDARD_DEVIATION 11.7 • n=5 Participants
Glycaemia	2.70 g/l STANDARD_DEVIATION 1.05 • n=5 Participants	2.39 g/l STANDARD_DEVIATION 0.98 • n=7 Participants	2.50 g/l STANDARD_DEVIATION 1.01 • n=5 Participants
glycated hemoglobin	9.73 percent STANDARD_DEVIATION 2.16 • n=5 Participants	9.48 percent STANDARD_DEVIATION 2.38 • n=7 Participants	9.58 percent STANDARD_DEVIATION 2.29 • n=5 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: From 327, 309 (113 men and 196 women) patients benefit from ophthalmoscopy with a trained ophthalmologist. 18 patients (9 men and 9 women) didn't perform the test. Each patient having a diabetic retinopathy was treated by the ophtalmologist who performed the examination

• Conventional ophtalmoscopy has been used to screen for diabetic retinopathy by an ophtalmologist at his office.
• Retinal angiography was performed if indicated by the ophtalmologist

Outcome measures

Measure	Men Group n=113 Participants Patients were assessed for diabetic retinopathy.	Women Group n=196 Participants Patients were assessed for diabetic retinopathy.
Number and Prevalence of Patients With Diabetic Retinopathy	9 Participants	18 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: We exclude from analysis 10 patients (2 men and 8 women) with neuropathy because of other possible etiology (8 hypothyroidism, 1 with B12 deficiency,1 with narrowed lumbar vertebra channel)

All 327 patients had a neurological examination by the same physician to screen for Distal Diabetic Neuropathy:

• Distal sensory testing: including 10 g monofilament test, vibration perception with 128 Hz tuning fork, temperature, touch , prickling and pain perception
• Ankles and knees reflex testing
• Muscle strength testing (quadriceps and tibialis anterior)
• We use the Michigan Neuropathy Screening Instrument score. We consider the diagnosis of Distal Diabetic Neuropathy if the score is up of 2 in at least one food. The MNSI score is ranged from 0 to 5 for each food
• Use of neuropathic pain score (DN4), if the DN4 is found up or egal to 4 we consider the diagnosis of neuropathic pain. The DN4 score is ranged from 0 to 10

Outcome measures

Measure	Men Group n=120 Participants Patients were assessed for diabetic retinopathy.	Women Group n=197 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Distal Diabetic Neuropathy	42 Participants	56 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: Of 327 patients, 317 had a complete screening for chronic kidney disease, 5 men and 5 women were excluded from analysis because of incomplete renal status.

• We screened for albuminuria or microalbuminuria in 24h urine collection with turbidimetry or immuno turbidimetry method ( performed 3 times in 4 or 6 months )
• Measurement of albumine- to- creatinine ratio (ACR), Albuminuria was diagnosed if ACR > or egal to 30 mg/g at least twice in 4 to 6 months. We ensure before performing ACR that there was no dysglycaemia, no urinary infection, no fever nor forced diuresis before we evaluate the urine sample.
• Cyto bacteriological examination and urine culture
• Serum creatinine repeated 2 to 3 time within 4 to 6 months
• Glomerular filtration rate was assessed with the Modification of Diet in Renal disease study equation (MDRD)
• Renal and urine tract echography to measure the kidneys and to screen for urine tract dilatation We made the diagnosis of Chronic Kidney Disease (CKD) if the glomerular filtration rate was < 60 ml/min/1.73 m² and/or ACR > or equal to 30 mg/g with a permanent character

Outcome measures

Measure	Men Group n=117 Participants Patients were assessed for diabetic retinopathy.	Women Group n=200 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Chronic Kidney Disease (CKD)	35 Participants	43 Participants

PRIMARY outcome

Timeframe: At recruitment

• Blood pressure measurement by electronic tensiometer (OMRON 3 or 4) on the right and left arm, after 10 mn of supine position.
• Three measures were performed with respect of one minute interval between each measure.
• Mean blood pressure is calculated
• Three other measures are performed in Three ulterior consultations
• Hypertension is diagnosed if the mean blood pressure >= 140 /90 mm Hg

Outcome measures

Measure	Men Group n=122 Participants Patients were assessed for diabetic retinopathy.	Women Group n=205 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Hypertension	82 Participants	136 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: 88.9 % (291 patients) had a screening for coronary heart disease. We performed an electrocardiogram in 325 cases, an echocardiography in 317 cases, a myocardial ischemic test in 291 cases (223 for silent myocardial ischemia: 85 men and 138 women) and a coronarography in 18 cases ( 8 men and 10 women, all had a positive myocardial ischemic test)

• 9 derivations resting electrocardiogram (ECG)
• Echocardiography
• Standard ECG stress test
• Stress Myocardial Perfusion scintigraphy if patients are not able to perform ECG stress test
• Coronary angiography if the exercise ECG stress test or stress myocardial perfusion scintigraphy suggest high probability of coronary heart disease

Outcome measures

Measure	Men Group n=85 Participants Patients were assessed for diabetic retinopathy.	Women Group n=138 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Silent Myocardial Ischemia	11 Participants	4 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: Lower limb duplex ultrasonography measurement has been done in 306 among 327 patients (111 men and 195 women). 21 patients, with a lack of data,were excluded from analysis. Chi 2 test was used for comparison of proportions.

• Search for history of intermittent claudication
• Complete vascular examination with Ankle-Brachial Index (ABI) measurement.
• Lower limb duplex ultrasonography.

Outcome measures

Measure	Men Group n=111 Participants Patients were assessed for diabetic retinopathy.	Women Group n=195 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Lower Extremity Artery Disease	6 Participants	12 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: From 327, 304 patients (109 men and 195 women) could perfom duplex ultrasonography of supra aortic trunks. We focus on the examination of external and internal carotids.

• Screening for carotid murmur at clinical examination by the same physician for all patients
• Carotid duplex ultrasonography with intima-media thickness measurement. All atherosclerotic lesions were reported.

Outcome measures

Measure	Men Group n=109 Participants Patients were assessed for diabetic retinopathy.	Women Group n=195 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Carotid Artery Stenosis	7 Participants	3 Participants

PRIMARY outcome

Timeframe: At recruitment

Population: From 327 we perform a duplex ultrasonography of renal arteries in 16 patients (6 men and 10 women) The number of participants analyzed is too small to have a statistical analysis.

• Renal artery duplex ultrasonography has been performed only if the patient presents a resistant hypertension treated with four drugs, including a diuretic or if blood pressure was over 180/10 mm Hg at recruitement.

Outcome measures

Measure	Men Group n=9 Participants Patients were assessed for diabetic retinopathy.	Women Group n=10 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index	2 Participants	2 Participants

PRIMARY outcome

Timeframe: at recruitment

Population: We screened 283 patients from 327 (100 men and 183 women). We excluded 44 patients from analysis (22 men and 22 women)cause of beta blocker treatment or high blood pressure, or diabetic retinopathy, or severe coronary heart disease and patients that could not perform deep breathing.

• Conditions of the Ewing tests: fasting, resting at least 30mn, no hypoglycemia and no effort within 24hours, no drugs that interfere with heart rate.
• Ewing Tests for cardiac autonomic neuropathy: Beat-to-Beat heart rate variation, Heart rate response to standing, Heart rate response to valsalva maneuver, Systolic blood pressure response to standing. All tests have been performed with the same physician and aid

Outcome measures

Measure	Men Group n=100 Participants Patients were assessed for diabetic retinopathy.	Women Group n=183 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Cardiac Autonomic Neuropathy	10 Participants	19 Participants

PRIMARY outcome

Timeframe: at recruitment

Population: From 327 we could screen 318 patients (118 men and 200 women) for bladder autonomic neuropathy. We performed a cystomanometry in 4 patients. We exclude, from analysis, 9 patients who didn't come to perform the post-voiding volume measurement.

• History of recurrent urine tract infection and/or dysuria and/or incomplete bladder emptying
• Post voiding residual(PVR) measurement with abdominal echography by a radiologist
• Cystomanometry is performed if PVR > 50 ml
• In men the prostatic measurement was made in all patients. In women, we measured the volume of uterus.

Outcome measures

Measure	Men Group n=118 Participants Patients were assessed for diabetic retinopathy.	Women Group n=200 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Bladder Autonomic Neuropathy	5 Participants	11 Participants

PRIMARY outcome

Timeframe: at recruitment

Population: An endoscopic examination has been performed in six women whose report vomiting, nausea or constipation. In the men's group no-one had an endoscopic examination.

• We interviewed all patient, looking for a history of post prandial discomfort or bad gastric emptying sensation or vomiting or unexplained diarrhea or constipation
• We performed an endoscopic examination to exclude other causes in patients with a positive history of gastro-intestinal troubles.

Outcome measures

Measure	Men Group n=122 Participants Patients were assessed for diabetic retinopathy.	Women Group n=205 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Gastro-intestinal Autonomic Neuropathy	0 Participants	6 Participants

PRIMARY outcome

Timeframe: at recruitment

• Questionary: onset , drug use, medical history, psycho- social conditions

Outcome measures

Measure	Men Group n=122 Participants Patients were assessed for diabetic retinopathy.	Women Group Patients were assessed for diabetic retinopathy.
Number of Patients With Erectile Dysfunction	63 Participants	—

SECONDARY outcome

Timeframe: One year after recruitment

Population: 305 patients (112 men and 193 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 22 patients (10 men and 12 women) from the analysis because of a lack of data, they were lost from follow-up. We include in analysis 5 patients who died the three first months during follow-up.

• We Record every documented acute coronary syndrome during follow-up;
• Each patient had an electrocardiogram every 3 months and during acute cardiovascular events;
• Echocardiography has been performed if indicated by the cardiologist.

Outcome measures

Measure	Men Group n=112 Participants Patients were assessed for diabetic retinopathy.	Women Group n=193 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With New Cardiac Events During Follow-up	7 Participants	2 Participants

SECONDARY outcome

Timeframe: One year after recruitment

Population: 300 patients (109 men and 191 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 27 patients (13 men and 14 women) from the analysis because of a lack of data. 22 patients (10 men and 12 women) were lost from follow-up and 5 died too early during follow-up (three first months).

• We assessed every new clinical signs of stroke with an interview searching for acute neurological symptoms and a clinical examination for all patients, from day one of recruitment to one year of follow-up;
• Tomodensitometry if there was a clinical presentation of stroke. Magnetic resonance imaging if transient ischemic attack was suspected.

Outcome measures

Measure	Men Group n=109 Participants Patients were assessed for diabetic retinopathy.	Women Group n=191 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With New Stroke or Transient Ischemic Attack	1 Participants	2 Participants

SECONDARY outcome

Timeframe: One year after recruitment

Population: 300 patients (109 men and 191 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 27 patients (13 men and 14 women) from the analysis because of a lack of data, 22 patients (10 men and 12 women) were lost from follow-up and 5 died too early during follow-up (three first months).

During one year of follow-up :

• We search for a recent history of intermittent claudication;
• We perform a systematic clinical examination with palpation of lower limb pulses and an Ankle-Brachial Index measurement after one year or in the presence of an acute ischemic lower limb episod ;
• Lower limb duplex sonography in the presence of an abnormal clinical vascular examination;
• Angiography in the presence of a lower limbs vascular event.

Outcome measures

Measure	Men Group n=109 Participants Patients were assessed for diabetic retinopathy.	Women Group n=191 Participants Patients were assessed for diabetic retinopathy.
Number of Patients With Lower Limbs Atherothrombotic Accident	0 Participants	1 Participants

SECONDARY outcome

Timeframe: One year after recruitment

Population: From 327 patients (122 men and 205 women) enrolled, 305 were followed-up one year or until death (112 men and 193 women). 22 patients (10 men and 12 women) were excluded from analysis because lost during follow-up.

• We recorded each death and its cause from a medical record after hospitalization in emergency units or phone contact with the patient's relatives to have some news. The record began with recruitment.

Outcome measures

Measure	Men Group n=112 Participants Patients were assessed for diabetic retinopathy.	Women Group n=193 Participants Patients were assessed for diabetic retinopathy.
Number of Patients That Died From Cardio Vascular Cause	3 Participants	2 Participants

Adverse Events

Men's Group

Serious events: 3 serious events

Other events: 18 other events

Deaths: 4 deaths

Women's Group

Serious events: 4 serious events

Other events: 29 other events

Deaths: 4 deaths

Serious adverse events

Measure	Men's Group n=109 participants at risk From 122 men at recruitment, 112 had been followed-up one year or until death. 109 had complete one year of follow-up.	Women's Group n=191 participants at risk From 205 women, 193 had been followed-up one year or until death. 191 women had complete one year of follow-up.
Vascular disorders Atherothrombotic event	2.8% 3/109 • Number of events 4 • One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications. During follow-up, we put in place a monitoring of any new clinical sign or biological change (renal or hepatic function). An assessment is performed regarding the new clinical or biological change.	2.1% 4/191 • Number of events 4 • One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications. During follow-up, we put in place a monitoring of any new clinical sign or biological change (renal or hepatic function). An assessment is performed regarding the new clinical or biological change.

Other adverse events

Measure	Men's Group n=109 participants at risk From 122 men at recruitment, 112 had been followed-up one year or until death. 109 had complete one year of follow-up.	Women's Group n=191 participants at risk From 205 women, 193 had been followed-up one year or until death. 191 women had complete one year of follow-up.
Vascular disorders New onset of permanent hypertension	13.8% 15/109 • One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications. During follow-up, we put in place a monitoring of any new clinical sign or biological change (renal or hepatic function). An assessment is performed regarding the new clinical or biological change.	13.1% 25/191 • One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications. During follow-up, we put in place a monitoring of any new clinical sign or biological change (renal or hepatic function). An assessment is performed regarding the new clinical or biological change.
Renal and urinary disorders Moderate acute renal insufficiency	2.8% 3/109 • One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications. During follow-up, we put in place a monitoring of any new clinical sign or biological change (renal or hepatic function). An assessment is performed regarding the new clinical or biological change.	2.1% 4/191 • One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications. During follow-up, we put in place a monitoring of any new clinical sign or biological change (renal or hepatic function). An assessment is performed regarding the new clinical or biological change.

Additional Information

Dr Wafia- Nadia Nibouche-Hattab

Algiers' university -1- Benyoucef Benkhedda, Faculty of Medicine Meherzi, Algiers.

Phone: +213771810932

Email: wani16000@yahoo.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place