The Effect of Intensive Lifestyle Interventions on Diabetes Type 2

Kenneth L. Smith, Mercer College of Pharmacy

Type 2 diabetes involves insulin resistance or the improper utilization of glucose when the cells fail to respond to insulin. Initial symptoms can involve frequent urination, increased thirst, and increased hunger. [1]  Other problems can involve heart disease, stroke, chronic kidney disease [2], foot ulcers [3], damage to the eyes, and many others.[4] First line treatment includes a combination of diet, physical activity, and weight loss in conjunction with pharmacological therapy.[5] It was pointed out that few studies have compared the effect of an intensive lifestyle intervention with the standard of care pharmacotherapy to maintain glycemic control in patients with type two diabetes.[6] In this randomized clinical trial, patients diagnosed with type two diabetes within the last ten years were treated then assessed for glycemic control using an A1c goal of 6.5%.[7]

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients

With Type 2 Diabetes [7]

Design Randomized, assessor-blinded, single-center study; N = 98
Objective To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes
Study Groups Lifestyle (n = 64); standard of care (n = 34)
Methods Participants were randomized in blocks of 3 or 6 then stratified by sex into either the lifestyle group or the standard of care group in a 2:1 ratio. The participants were recruited using media and assistance from the Danish Diabetes Association in addition to being screened through telephone interviews and medical examinations. Several exclusion criteria were used in addition to those that had an A1c ≥ 9% or were insulin dependent.
Duration April 2015 to August 2016
Primary Outcome Measure Change in A1c level from baseline to 12-month follow-up
Baseline Characteristics
Demographics Lifestyle Group Mean (SD)

(n = 64)

Standard of care group, Mean (SD) (n = 34)
Age at consent, y 53.6 (9.1) 56.6 (8.1)
Female, No. (%) 31 (48) 16 (47)
Type 2 diabetes duration,

median (IQR), y

5 (3 to 8) 6 (3 to 9)
Glycemic control
Hemoglobin A1c, % 6.65 (0.8) 6.74 (0.9)
Fasting glucose, median (IQR), mg/dL 131.5

(115.3 to 152.3)

 

140.5

(124.3 to 171.2)

Fasting insulin

median (IQR), μIU/mL

16 (11 to 23) 18 (9 to 29)
2-h glucose, mg/dL (n = 62/33) 15.1 (4.1) 16.3 (4.0)
Lipids
Total cholesterol, mg/dL 160.2 (33.1) 154.2 (37.0)
LDL, median (IQR), mg/dL 92.7

(71.4 to 112.0)

 

81.1

(69.5 to 96.5)

HDL, mg/dL 47.3 (13.2) 49.1 (13.3)
Triglycerides,

median (IQR), mg/dL

54.8

(39.2 to 74.9)

 

55.6

(34.7 to 69.9)

Blood pressure
Systolic, mm Hg 127 (14) (n = 60) 136 (8) (n = 24)
Diastolic, mm Hg 79 (8) (n = 60) 84 (8) (n = 24)
Body composition
Body mass, kg 94.7 (14.0) 98.1 (15.0)
BMI 31.4 (3.9) 32.5 (4.5)
Fat mass, kg 35.2 (9.2) 36.4 (9.2)
Lean body mass, kg 58.7 (10.8) 61.0 (10.7)
Abdominal fat mass, kg 4.0 (1.2) 4.2 (1.2)
Physical fitness,

physical activity, and diet

V˙ O2max, mL O2/min

2713 (717)

(n = 64)

2636 (742)

(n = 33)

Relative V˙ O2max,

mL O2/kg/min

28.7 (6.6)

(n = 64)

 

26.9 (6.2)

(n = 33)

Physical activity, median (IQR), met h/wk 61.9

(44.2 to 95.9)

(n = 59)

 

60.5

(50.1 to 121.5)

(n = 32)

Energy intake, median (IQR), kcal/d

 

2130

(1697 to 2563)

(n = 61)

2146

(1599 to 2637)

(n = 27)

 

Medication and Medication Scores
Glucose-lowering medication, No. (%)
None 1 (2) 0
Biguanide 50 (79) 27 (79)
Biguanide and GLP-1 analogue 13 (19) 7 (21)
Biguanide, GLP-1 analogue, and insulin 0 0
Glucose-lowering medication score, median (IQR) 3.0

(2.0 to 3.0)

 

3.0

(2.0 to 3.0)

 

Lipid-lowering medication, No. (%)
None 13 (20) 4 (12)

 

Statin 51 (80) 30 (88)

 

Lipid-lowering medication score, median (IQR) 3.0 (2.0 to 3.0)

 

4.0 (3.0 to 4.0)
Blood pressure–lowering medication, No. (%)
None 33 (52) 15 (44)
ARB 11 (17) 4 (12)
ARB and thiazide 11 (17) 8 (24)

 

ARB, thiazide, and calcium-channel blocker 9 (14) 7 (20)
Blood pressure–lowering medication score, median (IQR) 0.5 (0.0 to 4.0)

 

2.0 (0.0 to 5.0)
Results
  Lifestyle Standard of Care  
No. of patients Change (95% CI) No. of patients Change (95% CI) Between-Group Difference

(95% CI)

p value
Primary Outcome
A1c,% 64 −0.31(−0.45 to −0.16) 34 −0.04 (−0.25 to 1.17) −0.26 (−0.52 to −0.01)     .15
Adverse Events Common  Adverse Events: mild hypoglycemia (12.5% in lifestyle group, 0% in standard of care), musculoskeletal pain (14% in lifestyle group, 0% in standard of care), gastrointestinal problems (4% in  lifestyle group and 9% in standard care group), mild hypotension (6.3% in lifestyle group, 0% in standard of care), insomnia (0% in lifestyle group, 3% in standard of care group), peripheral edema (2% in lifestyle group and 3% in standard care group)
Serious Adverse Events: atrial fibrillation (2%)
Percentage that discontinued due to adverse events: N/A
Study Author Conclusions Patients that have had type 2 diabetes for less than 10 years showed a beneficial change in glycemic control when utilizing lifestyle changes compared to the standard of care. Further research is needed to study superiority, generalizability, and durability of these findings.

Although the intensive lifestyle intervention was found to be nonequivalent in maintaining glycemic controls, it did show a modest reduction in A1c values. The study highlights the impact that exercise and diet have on blood glucose levels and A1c values in patients with type two diabetes.  It also reveals the importance of a non-pharmacological treatment plan on diabetes management.

Dietary intake was self reported so it may have been possible for some volunteers to have indicated more or less healthier food selections then what was actually utilized leading to a potential bias in the study.

First-line medications were also used in order to compare lifestyle interventions using a prespecified treatment algorithm. This limited use of medications may have prevented the results from being generalized to other treatment plans.

 References:

[1] Kitabchi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglycemic crises in adult patients with diabetes. Diabetes Care. 2009;32(7):1335-43.

[2] Mokdad AH. Diabetes mellitus and chronic kidney disease in the Eastern Mediterranean Region: findings from the Global Burden of Disease 2015 study. Int J Public Health. 2017.

[3] Giurato L, Meloni M, Izzo V, Uccioli L. Osteomyelitis in diabetic foot: A comprehensive overview. World J Diabetes. 2017;8(4):135-142.

[4] Shih KC, Lam KS, Tong L. A systematic review on the impact of diabetes mellitus on the ocular surface. Nutr Diabetes. 2017;7(3):e251.

[5] American Diabetes Association. 6. Obesity Management for the Treatment of Type 2 Diabetes. Diabetes Care. 2016;39(suppl 1):S47-S51.

[6] Andrews RC, Cooper AR, Montgomery AA, et al. Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial. Lancet. 2011;378(9786):129-139.

[7] Johansen MY, Macdonald CS, Hansen KB, et al. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017;318(7):637-646.

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